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A Study in Advanced Cancer

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01226485
Collaborator
(none)
84
Enrollment
12
Locations
1
Arm
85
Duration (Months)
7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to find a recommended dose level and schedule of dosing LY2940680 that can safely be taken by participants with advanced cancer. The study will also explore the changes in a cancer marker level in skin, hair follicles, buccal cells, and tumor cells. Finally, the study will help document any antitumor activity this drug may have.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Participants may include those who have previously received treatment with another hedgehog smoothened (Hh/Smo) inhibitor (excluding LY2940680).

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Dose-Escalation Study of LY2940680 in Patients With Advanced Cancer
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Oct 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Taladegib

Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle. Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle. Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors. Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC).

Drug: Taladegib
Administered IV
Other Names:
  • LY2940680

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Recommended Phase 2 Dose: Maximum Tolerated Dose [Time to First Dose to the End of Cycle 1 of Part A (Up To 28 Days)]

      Recommended Phase 2 dose was determined by maximum tolerated dose (MTD), which was determined by Dose-limiting toxicity (DLT). For the purpose of this study, the MTD was defined as the highest tested dose that had <33% probability of causing a DLT in Cycle 1 of Part A.

    Secondary Outcome Measures

    1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) [Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h]

      Pharmacokinetics (PK): 1.Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])

    2. PK: Maximum Observed Drug Concentration (Cmax) [Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h]

      PK: Maximum Observed Drug Concentration (Cmax)

    3. PK: Time of Maximal Concentration (Tmax) [Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h]

      PK: Time of Maximal Concentration (Tmax)

    4. PK: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of LSN3185556 [Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h]

      PK: Area Under the Plasma Concentration-time Curve from time Zero to 24 Hours (AUC[0-24]) of LSN3185556

    5. PK: Maximum Observed Drug Concentration (Cmax) of LSN3185556 [Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h]

      PK: Maximum Observed Drug Concentration (Cmax) of LSN3185556

    6. PK: Time of Maximal Concentration (Tmax) of LSN3185556 [Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h]

      PK: Time of Maximal Concentration (Tmax)

    7. Number of Participants With Clinical Benefit Rate (Stable Disease [SD] + Partial Response [PR] + Complete Response [CR]) [Baseline to Disease Progression or Death Due to Any Cause (Up To 32 Months)]

      Clinical Benefit Rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is a ≥20% increase in the sum of diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 millimeter (mm), the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions.

    8. Part C and D: Progression Free Survival (PFS) [Baseline to Progressive Disease or Death from Any Cause (Up To 32 Months)]

      For each participant in Part C and D who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, PFS was censored at the date of last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy. Progressive disease (PD) was determined using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy.

    • Have the presence of measurable or nonmeasurable disease

    • Have adequate organ function, including:

    • Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L, platelets greater than or equal to 100 x 109/L, and hemoglobin greater than or equal to 9 g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin until 5 days after the erythrocyte transfusion.

    • Hepatic: Bilirubin less than or equal to 1.5 times upper limits of normal (ULN), ALT, and aspartate transferase (AST) less than or equal to 2.0 times ULN. If the liver has tumor involvement AST and ALT equaling less than or equal to 5 times ULN are acceptable.

    • Renal: Serum creatinine less than or equal to 1.5 times ULN.

    • Have a performance status of less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) scale

    • Have discontinued previous treatments for cancer and recovered from the acute effects of therapy (for example, at least 42 days for mitomycin-C or nitrosoureas, 28 days for other chemotherapy and biologics. At the discretion of the investigator, hormone refractory prostate cancer patients who are stable on gonadotropin-releasing hormone (GnRH) agonist therapy and breast cancer patients who are stable on antiestrogen therapy (for example, an aromatase inhibitor) may continue treatment

    Exclusion Criteria:

    • Have received treatment within 21 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication.

    • Have serious preexisting medical conditions

    • Have symptomatic central nervous system (CNS) malignancy (with the exception of medulloblastoma) or metastasis (screening not required). Patients with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 60 days.

    • Have known current hematologic malignancies or acute or chronic leukemia

    • Have a known active fungal, bacterial, and/or known viral infection including human immunodeficiency (HIV) or viral (A, B, or C) hepatitis (screening is not required)

    • Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results

    • Have QTc interval of >500 msec on screening electrocardiogram

    • Patients who have previously received treatment with LY2940680

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Scottsdale Arizona United States 85260
    2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Redwood City California United States 94063
    3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Aurora Colorado United States 80045
    4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fort Myers Florida United States 33908
    5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tampa Florida United States 33612
    6 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Las Vegas Nevada United States 89169
    7 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New York New York United States 10065
    8 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Oklahoma City Oklahoma United States 73104
    9 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nashville Tennessee United States 37203
    10 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fort Worth Texas United States 76177
    11 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Houston Texas United States 77030
    12 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tyler Texas United States 75702

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01226485
    Other Study ID Numbers:
    • Lilly 13200
    • I4J-MC-HHBB
    First Posted:
    Oct 22, 2010
    Last Update Posted:
    Sep 13, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eli Lilly and Company
    Cancer
    Terminal
    Solid Tumor
    End Stage
    Metastatic
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Study completers are participants who received at least one dose of study drug and were evaluated for safety. Part B of the study was not implemented as the estimated half-life was considered long enough for once a day (QD) dosing.
    Arm/Group Title Part A: Cohort 1 Part A: Cohort 2 Part A: Cohort 3 Part A: Cohort 4 Part A: Cohort 5 Part C Part D
    Arm/Group Description Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle. Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle. Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors. Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC).
    Period Title: Overall Study
    STARTED 3 6 3 6 7 19 40
    Received at Least One Dose of Drug 3 6 3 6 7 19 40
    COMPLETED 3 6 3 6 7 19 40
    NOT COMPLETED 0 0 0 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Part A: Cohort 1 Part A: Cohort 2 Part A: Cohort 3 Part A: Cohort 4 Part A: Cohort 5 Part C Part D Total
    Arm/Group Description Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle. Part A Cohort 2 : 100 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle. Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors. Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC). Total of all reporting groups
    Overall Participants 3 6 3 6 7 19 40 84
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    60.3
    (14.57)
    57.2
    (14.18)
    67.3
    (7.37)
    60.7
    (14.05)
    65.6
    (11.34)
    62.5
    (10.59)
    64.0
    (12.47)
    63.1
    (11.92)
    Sex: Female, Male (Count of Participants)
    Female
    1
    33.3%
    2
    33.3%
    1
    33.3%
    3
    50%
    2
    28.6%
    6
    31.6%
    8
    20%
    23
    27.4%
    Male
    2
    66.7%
    4
    66.7%
    2
    66.7%
    3
    50%
    5
    71.4%
    13
    68.4%
    32
    80%
    61
    72.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    1
    5.3%
    2
    5%
    4
    4.8%
    Not Hispanic or Latino
    3
    100%
    6
    100%
    2
    66.7%
    6
    100%
    7
    100%
    18
    94.7%
    38
    95%
    80
    95.2%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    5%
    2
    2.4%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    5.3%
    1
    2.5%
    2
    2.4%
    White
    3
    100%
    6
    100%
    3
    100%
    6
    100%
    7
    100%
    18
    94.7%
    36
    90%
    79
    94%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    2.5%
    1
    1.2%
    Region of Enrollment (Count of Participants)
    United States
    3
    100%
    6
    100%
    3
    100%
    6
    100%
    7
    100%
    19
    100%
    40
    100%
    84
    100%

    Outcome Measures

    1. Primary Outcome
    Title Recommended Phase 2 Dose: Maximum Tolerated Dose
    Description Recommended Phase 2 dose was determined by maximum tolerated dose (MTD), which was determined by Dose-limiting toxicity (DLT). For the purpose of this study, the MTD was defined as the highest tested dose that had <33% probability of causing a DLT in Cycle 1 of Part A.
    Time Frame Time to First Dose to the End of Cycle 1 of Part A (Up To 28 Days)

    Outcome Measure Data

    Analysis Population Description
    Part A participants who received at least one dose of study drug.
    Arm/Group Title All Part A Participants
    Arm/Group Description Part A: Cohort 1 Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle. Part A: Cohort 2 Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle. Part A: Cohort 3 Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle. Part A: Cohort 4 Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle. Part A: Cohort 5 Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle.
    Measure Participants 25
    Number [milligrams (mg)]
    400
    2. Secondary Outcome
    Title Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])
    Description Pharmacokinetics (PK): 1.Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])
    Time Frame Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug and had evaluable PK data. All participants who received 400 mg taladegib were analyzed together.
    Arm/Group Title 50 mg Taladegib 100 mg Taladegib 200 mg Taladegib 400 mg Taladegib 600 mg Taladegib
    Arm/Group Description 50 milligram (mg) taladegib administered orally QD on a 28-day cycle. 100 mg taladegib administered orally QD on a 28-day cycle. 200 mg taladegib administered orally QD on a 28-day cycle. 400 mg taladegib administered orally QD on a 28-day cycle. 600 mg taladegib administered orally QD on a 28-day cycle.
    Measure Participants 3 6 3 63 7
    Cycle 1, Day 1
    NA
    (NA)
    8.70
    (101)
    NA
    (NA)
    53.7
    (99.1)
    96.2
    (74.8)
    Cycle 1, Day 15
    NA
    (NA)
    12.4
    (113)
    NA
    (NA)
    93.8
    (103)
    NA
    (NA)
    3. Secondary Outcome
    Title PK: Maximum Observed Drug Concentration (Cmax)
    Description PK: Maximum Observed Drug Concentration (Cmax)
    Time Frame Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug and had evaluable PK data. All participants who received 400 mg taladegib were analyzed together.
    Arm/Group Title 50 mg Taladegib 100 mg Taladegib 200 mg Taladegib 400 mg Taladegib 600 mg Taladegib
    Arm/Group Description 50 milligram (mg) taladegib administered orally QD on a 28-day cycle. 100 mg taladegib administered orally QD on a 28-day cycle. 200 mg taladegib administered orally QD on a 28-day cycle. 400 mg taladegib administered orally QD on a 28-day cycle. 600 mg taladegib administered orally QD on a 28-day cycle.
    Measure Participants 3 6 3 63 7
    Cycle 1, Day 1
    NA
    (NA)
    0.45
    (59.87)
    1.29
    (NA)
    2.07
    (66.39)
    3.28
    (34.36)
    Cycle 1, Day 15
    NA
    (NA)
    0.71
    (71.67)
    NA
    (NA)
    3.62
    (59.00)
    NA
    (NA)
    4. Secondary Outcome
    Title PK: Time of Maximal Concentration (Tmax)
    Description PK: Time of Maximal Concentration (Tmax)
    Time Frame Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug and had evaluable PK data. All participants who received 400 mg taladegib were analyzed together.
    Arm/Group Title 50 mg Taladegib 100 mg Taladegib 200 mg Taladegib 400 mg Taladegib 600 mg Taladegib
    Arm/Group Description 50 milligram (mg) taladegib administered orally QD on a 28-day cycle. 100 mg taladegib administered orally QD on a 28-day cycle. 200 mg taladegib administered orally QD on a 28-day cycle. 400 mg taladegib administered orally QD on a 28-day cycle. 600 mg taladegib administered orally QD on a 28-day cycle.
    Measure Participants 3 6 3 63 7
    Cycle 1, Day 1
    2.03
    3.92
    1.22
    2.00
    3.82
    Cycle 1,Day 15
    2.0
    4.10
    1.00
    2.00
    4.08
    5. Secondary Outcome
    Title PK: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of LSN3185556
    Description PK: Area Under the Plasma Concentration-time Curve from time Zero to 24 Hours (AUC[0-24]) of LSN3185556
    Time Frame Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug and had evaluable PK data. All participants who received 400 mg taladegib were analyzed together.
    Arm/Group Title 50 mg Taladegib 100 mg Taladegib 200 mg Taladegib 400 mg Taladegib 600 mg Taladegib
    Arm/Group Description 50 milligram (mg) taladegib administered orally QD on a 28-day cycle. 100 mg taladegib administered orally QD on a 28-day cycle. 200 mg taladegib administered orally QD on a 28-day cycle. 400 mg taladegib administered orally QD on a 28-day cycle. 600 mg taladegib administered orally QD on a 28-day cycle.
    Measure Participants 3 6 3 63 7
    Cycle 1, Day 1
    NA
    (NA)
    7.91
    (50.1)
    NA
    (NA)
    36.6
    (70.1)
    67.4
    (67.7)
    Cycle 1, Day 15
    NA
    (NA)
    22.9
    (67.6)
    NA
    (NA)
    121
    (81.0)
    NA
    (NA)
    6. Secondary Outcome
    Title PK: Maximum Observed Drug Concentration (Cmax) of LSN3185556
    Description PK: Maximum Observed Drug Concentration (Cmax) of LSN3185556
    Time Frame Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug and had evaluable PK data. All participants who received 400 mg taladegib were analyzed together.
    Arm/Group Title 50 mg Taladegib 100 mg Taladegib 200 mg Taladegib 400 mg Taladegib 600 mg Taladegib
    Arm/Group Description 50 milligram (mg) taladegib administered orally QD on a 28-day cycle. 100 mg taladegib administered orally QD on a 28-day cycle. 200 mg taladegib administered orally QD on a 28-day cycle. 400 mg taladegib administered orally QD on a 28-day cycle. 600 mg taladegib administered orally QD on a 28-day cycle.
    Measure Participants 3 6 3 63 7
    Cycle 1, Day 1
    NA
    (NA)
    0.51
    (37.28)
    NA
    (NA)
    2.27
    (62.82)
    4.18
    (73.72)
    Cycle 1, Day 15
    NA
    (NA)
    1.53
    (60.18)
    NA
    (NA)
    7.18
    (72.20)
    NA
    (NA)
    7. Secondary Outcome
    Title PK: Time of Maximal Concentration (Tmax) of LSN3185556
    Description PK: Time of Maximal Concentration (Tmax)
    Time Frame Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug and had evaluable PK data. All participants who received 400 mg taladegib were analyzed together.
    Arm/Group Title 50 mg Taladegib 100 mg Taladegib 200 mg Taladegib 400 mg Taladegib 600 mg Taladegib
    Arm/Group Description 50 milligram (mg) taladegib administered orally QD on a 28-day cycle. 100 mg taladegib administered orally QD on a 28-day cycle. 200 mg taladegib administered orally QD on a 28-day cycle. 400 mg taladegib administered orally QD on a 28-day cycle. 600 mg taladegib administered orally QD on a 28-day cycle.
    Measure Participants 3 6 3 63 7
    Cycle 1, Day 1
    24.25
    16.81
    6.00
    22.67
    24.00
    Cycle 1,Day 15
    8.00
    8.99
    8.00
    1.74
    8.00
    8. Secondary Outcome
    Title Number of Participants With Clinical Benefit Rate (Stable Disease [SD] + Partial Response [PR] + Complete Response [CR])
    Description Clinical Benefit Rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is a ≥20% increase in the sum of diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 millimeter (mm), the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions.
    Time Frame Baseline to Disease Progression or Death Due to Any Cause (Up To 32 Months)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug.
    Arm/Group Title Part A: Cohort 1 Part A: Cohort 2 Part A: Cohort 3 Part A: Cohort 4 Part A: Cohort 5 Part C Part D
    Arm/Group Description Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle. Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle. Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors. Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC).
    Measure Participants 3 6 3 6 7 19 40
    Count of Participants [Participants]
    2
    66.7%
    1
    16.7%
    2
    66.7%
    1
    16.7%
    2
    28.6%
    4
    21.1%
    37
    92.5%
    9. Secondary Outcome
    Title Part C and D: Progression Free Survival (PFS)
    Description For each participant in Part C and D who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, PFS was censored at the date of last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy. Progressive disease (PD) was determined using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
    Time Frame Baseline to Progressive Disease or Death from Any Cause (Up To 32 Months)

    Outcome Measure Data

    Analysis Population Description
    Part C and Part D participants who received at least one dose of study drug and had evaluable PFS data. Participants censored were Part C=8 and Part D=22. Per protocol, Part A data were not collected for PFS.
    Arm/Group Title Part C Part D
    Arm/Group Description Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors. Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC).
    Measure Participants 11 18
    Median (95% Confidence Interval) [months]
    1.74
    9.07

    Adverse Events

    Time Frame
    Adverse Event Reporting Description All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
    Arm/Group Title Part A: Cohort 1 Part A: Cohort 2 Part A: Cohort 3 Part A: Cohort 4 Part A: Cohort 5 Part C Part D
    Arm/Group Description Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle. Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle. Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors. Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC).
    All Cause Mortality
    Part A: Cohort 1 Part A: Cohort 2 Part A: Cohort 3 Part A: Cohort 4 Part A: Cohort 5 Part C Part D
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Part A: Cohort 1 Part A: Cohort 2 Part A: Cohort 3 Part A: Cohort 4 Part A: Cohort 5 Part C Part D
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/3 (0%) 3/6 (50%) 0/3 (0%) 3/6 (50%) 1/7 (14.3%) 4/19 (21.1%) 10/40 (25%)
    Blood and lymphatic system disorders
    Anaemia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Gastrointestinal disorders
    Abdominal pain 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Colitis 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Gastrointestinal haemorrhage 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Nausea 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 2/6 (33.3%) 2 1/7 (14.3%) 1 0/19 (0%) 0 1/40 (2.5%) 1
    Pancreatitis 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Vomiting 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 1/7 (14.3%) 1 0/19 (0%) 0 0/40 (0%) 0
    General disorders
    Death 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Fatigue 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Infections and infestations
    Catheter site abscess 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Catheter site cellulitis 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Clostridium difficile infection 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Device related infection 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Gastroenteritis viral 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Pneumonia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/19 (10.5%) 2 0/40 (0%) 0
    Sepsis 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Staphylococcal infection 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Urinary tract infection 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 2
    Metabolism and nutrition disorders
    Hyponatraemia 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Back pain 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 2
    Muscle spasms 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Musculoskeletal pain 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Nervous system disorders
    Headache 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Syncope 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Pneumothorax 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Other (Not Including Serious) Adverse Events
    Part A: Cohort 1 Part A: Cohort 2 Part A: Cohort 3 Part A: Cohort 4 Part A: Cohort 5 Part C Part D
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/3 (100%) 6/6 (100%) 3/3 (100%) 6/6 (100%) 7/7 (100%) 19/19 (100%) 40/40 (100%)
    Blood and lymphatic system disorders
    Anaemia 0/3 (0%) 0 1/6 (16.7%) 2 0/3 (0%) 0 2/6 (33.3%) 2 0/7 (0%) 0 0/19 (0%) 0 5/40 (12.5%) 5
    Leukocytosis 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Neutropenia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 0/40 (0%) 0
    Cardiac disorders
    Palpitations 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/19 (0%) 0 2/40 (5%) 2
    Ear and labyrinth disorders
    Cerumen impaction 0/3 (0%) 0 0/6 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Ear pain 0/3 (0%) 0 0/6 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Hyperacusis 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 0/40 (0%) 0
    Eye disorders
    Blepharitis 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Eye irritation 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Photophobia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 0/40 (0%) 0
    Pinguecula 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Vision blurred 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 1/7 (14.3%) 1 2/19 (10.5%) 2 2/40 (5%) 2
    Visual impairment 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 1/40 (2.5%) 1
    Gastrointestinal disorders
    Abdominal discomfort 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 1/40 (2.5%) 1
    Abdominal distension 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Abdominal pain 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 6/40 (15%) 6
    Abdominal pain lower 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Abdominal pain upper 0/3 (0%) 0 2/6 (33.3%) 2 1/3 (33.3%) 2 0/6 (0%) 0 0/7 (0%) 0 2/19 (10.5%) 2 2/40 (5%) 4
    Constipation 0/3 (0%) 0 1/6 (16.7%) 1 1/3 (33.3%) 1 2/6 (33.3%) 2 0/7 (0%) 0 5/19 (26.3%) 5 14/40 (35%) 15
    Diarrhoea 3/3 (100%) 3 3/6 (50%) 3 1/3 (33.3%) 1 1/6 (16.7%) 1 1/7 (14.3%) 1 3/19 (15.8%) 4 13/40 (32.5%) 17
    Dry mouth 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/19 (10.5%) 2 2/40 (5%) 2
    Dyspepsia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 2/40 (5%) 2
    Dysphagia 0/3 (0%) 0 2/6 (33.3%) 2 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 5/40 (12.5%) 5
    Faeces discoloured 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 1/40 (2.5%) 1
    Flatulence 0/3 (0%) 0 2/6 (33.3%) 2 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Gastrooesophageal reflux disease 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 2/40 (5%) 3
    Nausea 1/3 (33.3%) 1 3/6 (50%) 4 2/3 (66.7%) 3 2/6 (33.3%) 2 4/7 (57.1%) 4 8/19 (42.1%) 9 24/40 (60%) 37
    Rectal haemorrhage 0/3 (0%) 0 0/6 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Salivary hypersecretion 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 1/40 (2.5%) 1
    Vomiting 1/3 (33.3%) 1 2/6 (33.3%) 2 1/3 (33.3%) 1 5/6 (83.3%) 6 3/7 (42.9%) 5 7/19 (36.8%) 12 16/40 (40%) 27
    General disorders
    Asthenia 1/3 (33.3%) 1 0/6 (0%) 0 1/3 (33.3%) 1 1/6 (16.7%) 1 2/7 (28.6%) 2 3/19 (15.8%) 3 3/40 (7.5%) 3
    Chills 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Cyst 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Early satiety 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 2/40 (5%) 2
    Fatigue 3/3 (100%) 3 1/6 (16.7%) 1 2/3 (66.7%) 2 4/6 (66.7%) 4 4/7 (57.1%) 5 9/19 (47.4%) 9 24/40 (60%) 26
    Feeling jittery 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Gait disturbance 0/3 (0%) 0 0/6 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 1/40 (2.5%) 1
    Influenza like illness 1/3 (33.3%) 1 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Mucosal inflammation 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Non-cardiac chest pain 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/19 (10.5%) 2 1/40 (2.5%) 1
    Oedema peripheral 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 2/19 (10.5%) 2 1/40 (2.5%) 1
    Pyrexia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 2 1/19 (5.3%) 1 3/40 (7.5%) 3
    Hepatobiliary disorders
    Hepatic pain 1/3 (33.3%) 1 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Hyperbilirubinaemia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 1/7 (14.3%) 1 0/19 (0%) 0 1/40 (2.5%) 1
    Immune system disorders
    Seasonal allergy 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 2/40 (5%) 2
    Infections and infestations
    Bronchitis 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Cellulitis 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 3/40 (7.5%) 3
    Furuncle 1/3 (33.3%) 1 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Infected cyst 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Nasopharyngitis 1/3 (33.3%) 1 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 2/40 (5%) 2
    Pneumonia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Respiratory tract infection 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Sinusitis 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/19 (10.5%) 2 1/40 (2.5%) 1
    Skin infection 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Upper respiratory tract infection 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 2/40 (5%) 2
    Urinary tract infection 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 2/40 (5%) 2
    Viral upper respiratory tract infection 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Injury, poisoning and procedural complications
    Contusion 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/19 (10.5%) 2 0/40 (0%) 0
    Exposure to toxic agent 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Fall 1/3 (33.3%) 1 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 1/40 (2.5%) 1
    Laceration 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 0/40 (0%) 0
    Mouth injury 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Skin abrasion 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Thermal burn 0/3 (0%) 0 0/6 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Investigations
    Alanine aminotransferase increased 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 1/19 (5.3%) 1 1/40 (2.5%) 1
    Aspartate aminotransferase increased 1/3 (33.3%) 1 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 1/19 (5.3%) 1 1/40 (2.5%) 1
    Blood alkaline phosphatase increased 1/3 (33.3%) 1 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 1/40 (2.5%) 1
    Blood bilirubin increased 1/3 (33.3%) 1 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 1/40 (2.5%) 1
    Blood creatine phosphokinase increased 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 4/40 (10%) 6
    Blood creatinine increased 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 1/19 (5.3%) 1 2/40 (5%) 3
    Blood lactate dehydrogenase increased 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Blood urea increased 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 1/19 (5.3%) 1 0/40 (0%) 0
    International normalised ratio increased 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 0/40 (0%) 0
    Lymphocyte count decreased 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Neutrophil count increased 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Weight decreased 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 5/19 (26.3%) 6 21/40 (52.5%) 23
    Metabolism and nutrition disorders
    Decreased appetite 1/3 (33.3%) 1 1/6 (16.7%) 1 2/3 (66.7%) 2 2/6 (33.3%) 2 3/7 (42.9%) 3 10/19 (52.6%) 11 17/40 (42.5%) 17
    Dehydration 1/3 (33.3%) 2 1/6 (16.7%) 1 0/3 (0%) 0 2/6 (33.3%) 5 1/7 (14.3%) 1 0/19 (0%) 0 3/40 (7.5%) 4
    Failure to thrive 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 0/40 (0%) 0
    Hypercalcaemia 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 2/40 (5%) 2
    Hyperkalaemia 1/3 (33.3%) 1 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 4/40 (10%) 4
    Hyperuricaemia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 0/40 (0%) 0
    Hypoglycaemia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 0/40 (0%) 0
    Hypokalaemia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 1/7 (14.3%) 1 2/19 (10.5%) 2 1/40 (2.5%) 1
    Hyponatraemia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 1/19 (5.3%) 1 3/40 (7.5%) 4
    Tetany 0/3 (0%) 0 0/6 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Vitamin d deficiency 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/3 (33.3%) 1 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 2 2/19 (10.5%) 3 3/40 (7.5%) 3
    Back pain 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/19 (10.5%) 2 1/40 (2.5%) 1
    Flank pain 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Intervertebral disc protrusion 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/19 (10.5%) 2 0/40 (0%) 0
    Joint lock 1/3 (33.3%) 1 0/6 (0%) 0 1/3 (33.3%) 2 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Muscle spasms 2/3 (66.7%) 6 2/6 (33.3%) 2 2/3 (66.7%) 4 0/6 (0%) 0 1/7 (14.3%) 1 6/19 (31.6%) 12 23/40 (57.5%) 38
    Muscular weakness 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 3/19 (15.8%) 3 1/40 (2.5%) 1
    Musculoskeletal pain 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 1/19 (5.3%) 1 0/40 (0%) 0
    Myalgia 1/3 (33.3%) 1 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 5/19 (26.3%) 5 11/40 (27.5%) 13
    Neck pain 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 3/40 (7.5%) 3
    Pain in extremity 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 1/19 (5.3%) 1 2/40 (5%) 2
    Pain in jaw 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 3/40 (7.5%) 3
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 1/40 (2.5%) 1
    Tumour flare 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Nervous system disorders
    Dizziness 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 2/19 (10.5%) 3 13/40 (32.5%) 16
    Dizziness postural 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Dysgeusia 2/3 (66.7%) 3 3/6 (50%) 3 2/3 (66.7%) 4 1/6 (16.7%) 1 4/7 (57.1%) 4 8/19 (42.1%) 9 23/40 (57.5%) 26
    Headache 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 1/6 (16.7%) 1 1/7 (14.3%) 1 2/19 (10.5%) 4 7/40 (17.5%) 13
    Hypoaesthesia 1/3 (33.3%) 1 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 1/40 (2.5%) 1
    Memory impairment 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 2/40 (5%) 2
    Monoplegia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Neuralgia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Neuropathy peripheral 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/19 (10.5%) 2 1/40 (2.5%) 1
    Parosmia 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Peripheral sensory neuropathy 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 4/40 (10%) 6
    Presyncope 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/19 (10.5%) 4 0/40 (0%) 0
    Somnolence 1/3 (33.3%) 1 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Syncope 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Tremor 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 2/7 (28.6%) 2 2/19 (10.5%) 2 0/40 (0%) 0
    Psychiatric disorders
    Anxiety 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 2/6 (33.3%) 2 0/7 (0%) 0 0/19 (0%) 0 2/40 (5%) 2
    Confusional state 1/3 (33.3%) 1 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 1/19 (5.3%) 1 1/40 (2.5%) 1
    Depression 0/3 (0%) 0 0/6 (0%) 0 1/3 (33.3%) 1 1/6 (16.7%) 1 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Insomnia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 5/40 (12.5%) 5
    Nightmare 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Paranoia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Substance-induced psychotic disorder 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 0/40 (0%) 0
    Renal and urinary disorders
    Dysuria 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 1/6 (16.7%) 1 1/7 (14.3%) 1 1/19 (5.3%) 1 2/40 (5%) 2
    Glycosuria 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 0/40 (0%) 0
    Haematuria 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 2/40 (5%) 2
    Nephrolithiasis 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Urinary incontinence 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 1/40 (2.5%) 1
    Reproductive system and breast disorders
    Prostatitis 0/2 (0%) 0 0/4 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 1/13 (7.7%) 1 0/32 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 5/19 (26.3%) 5 10/40 (25%) 10
    Dyspnoea 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 3/19 (15.8%) 3 3/40 (7.5%) 4
    Dyspnoea exertional 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Hiccups 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Hypoxia 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 2 0/40 (0%) 0
    Nasal congestion 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Paranasal sinus hypersecretion 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 1/40 (2.5%) 1
    Rhinorrhoea 1/3 (33.3%) 1 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/19 (0%) 0 0/40 (0%) 0
    Sinus congestion 1/3 (33.3%) 1 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 2/40 (5%) 2
    Skin and subcutaneous tissue disorders
    Alopecia 2/3 (66.7%) 2 1/6 (16.7%) 1 2/3 (66.7%) 2 0/6 (0%) 0 1/7 (14.3%) 1 4/19 (21.1%) 4 21/40 (52.5%) 22
    Dermatitis acneiform 0/3 (0%) 0 0/6 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Dry skin 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 1/19 (5.3%) 1 1/40 (2.5%) 1
    Night sweats 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/19 (10.5%) 2 0/40 (0%) 0
    Photosensitivity reaction 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 2 2/40 (5%) 2
    Rash 2/3 (66.7%) 3 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/19 (10.5%) 2 2/40 (5%) 2
    Rash maculo-papular 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 1/19 (5.3%) 1 3/40 (7.5%) 3
    Rash pruritic 1/3 (33.3%) 1 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Skin burning sensation 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Skin ulcer 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Urticaria 0/3 (0%) 0 0/6 (0%) 0 1/3 (33.3%) 2 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0
    Surgical and medical procedures
    Surgery 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/19 (5.3%) 1 0/40 (0%) 0
    Vascular disorders
    Hot flush 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/19 (0%) 0 1/40 (2.5%) 1
    Hypertension 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 6/40 (15%) 6
    Hypotension 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/19 (0%) 0 3/40 (7.5%) 3
    Orthostatic hypotension 1/3 (33.3%) 1 0/6 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/19 (0%) 0 0/40 (0%) 0

    Limitations/Caveats

    Part B of the study was not implemented as the estimated half-life was considered long enough for QD dosing.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email ClinicalTrials.gov@lilly.com
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01226485
    Other Study ID Numbers:
    • Lilly 13200
    • I4J-MC-HHBB
    First Posted:
    Oct 22, 2010
    Last Update Posted:
    Sep 13, 2019
    Last Verified:
    Aug 1, 2019