A Study of LY3314814 in Healthy Participants
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT03222427
Collaborator
Eli Lilly and Company (Industry)
8
1
2
1.1
7.6
Study Details
Study Description
Brief Summary
The purpose of this study is to measure how much LY3314814 gets into the bloodstream when it is given as a single dose by mouth and as an intravenous (IV) infusion over two hours. The study will last at least two weeks for each participant, not including screening.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
8 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
Open label
Primary Purpose:
Basic Science
Official Title:
An Absolute Bioavailability Study of LY3314814 in Healthy Subjects Using an Intravenous Tracer Method
Actual Study Start Date
:
Jan 15, 2018
Actual Primary Completion Date
:
Feb 16, 2018
Actual Study Completion Date
:
Feb 16, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY3314814 Single 50 milligram (mg) dose of LY3314814 administered orally |
Drug: LY3314814
Administered orally
|
| Experimental: [13C415N3] LY3314814 Single 100 micrograms (μg) intravenous (IV) dose of [13C415N3] LY3314814 administered as an IV infusion. |
Drug: [13C415N3] LY3314814
Administered as an IV infusion
|
Outcome Measures
Primary Outcome Measures
- Absolute Bioavailability of LY3314814 [Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose]
Absolute bioavailability was quantified using a mixed-effects analysis of variance (ANOVA) model applied to the log-transformed dose-normalized AUC(0-∞) of LY3314814 oral dosing and IV administered [13C415N3]-LY3314814.
Secondary Outcome Measures
- Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814 [Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose]
Pharmacokinetics: Area Under the Drug Concentration-Time Curve from Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Are overtly healthy males or females
-
Have venous access sufficient to allow for blood sampling and intravenous (IV) administration of the investigational product
Exclusion Criteria:
-
Have a history of significant ophthalmic disease
-
Have vitiligo or any other clinically significant disorder of skin pigmentation
-
Have a history of use of antipsychotic drugs, or chronic use of antidepressant or anxiolytic drugs, prescribed as well as non-prescribed
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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Leeds | West Yorkshire | United Kingdom |
Sponsors and Collaborators
- AstraZeneca
- 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)
More Information
Additional Information:
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT03222427
Other Study ID Numbers:
- 15993
- I8D-MC-AZEP
- 2017-001181-18
First Posted:
Jul 19, 2017
Last Update Posted:
Oct 31, 2019
Last Verified:
Oct 1, 2019
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | LY3314814 + [13C415N3] LY3314814 |
|---|---|
| Arm/Group Description | Single 50 milligram (mg) dose of LY3314814 administered orally simultaneously with a single 100 microgram (μg) intravenous (IV) infusion of [13C415N3] LY3314814 over 2 hours on Day 1. |
| Period Title: Overall Study | |
| STARTED | 8 |
| Received One Dose of Study Drug | 8 |
| COMPLETED | 8 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | LY3314814 + [13C415N3] LY3314814 |
|---|---|
| Arm/Group Description | Single 50 milligram (mg) dose of LY3314814 administered orally simultaneously with a single 100 microgram (μg) intravenous (IV) infusion of [13C415N3] LY3314814 over 2 hours on Day 1. |
| Overall Participants | 8 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
52.3
(9.8)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
3
37.5%
|
| Male |
5
62.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
8
100%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
8
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (Count of Participants) | |
| United Kingdom |
8
100%
|
Outcome Measures
| Title | Absolute Bioavailability of LY3314814 |
|---|---|
| Description | Absolute bioavailability was quantified using a mixed-effects analysis of variance (ANOVA) model applied to the log-transformed dose-normalized AUC(0-∞) of LY3314814 oral dosing and IV administered [13C415N3]-LY3314814. |
| Time Frame | Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of study drug and have evaluable PK data. |
| Arm/Group Title | LY3314814 | [13C415N3] LY3314814 |
|---|---|---|
| Arm/Group Description | Single 50 mg dose of LY3314814 administered orally. | Single 100 μg IV dose of [13C415N3] LY3314814 administered as an IV infusion. |
| Measure Participants | 8 | 7 |
| Geometric Mean (Geometric Coefficient of Variation) [nanogram*hour per milliliter per mg] |
60.5
(41)
|
59.2
(17)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | LY3314814, [13C415N3] LY3314814 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of Geometric Least Squares Means |
| Estimated Value | 0.952 | |
| Confidence Interval |
(2-Sided) 90% 0.769 to 1.18 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814 |
|---|---|
| Description | Pharmacokinetics: Area Under the Drug Concentration-Time Curve from Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814 |
| Time Frame | Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received one dose of study drug and had evaluable PK data. |
| Arm/Group Title | LY3314814 | [13C415N3] LY3314814 |
|---|---|---|
| Arm/Group Description | Single 50 mg dose of LY3314814 administered orally. | Single 100 μg IV dose of [13C415N3] LY3314814 administered as an IV infusion. |
| Measure Participants | 8 | 7 |
| Geometric Mean (Geometric Coefficient of Variation) [nanogram*hour per milliliter (ng*hr/mL)] |
3020
(41)
|
5.92
(17)
|
Adverse Events
| Time Frame | From baseline to end of study (Up To 7 days) | |
|---|---|---|
| Adverse Event Reporting Description | All participants who have received at least one dose of study drug. | |
| Arm/Group Title | LY3314814 + [13C415N3] LY3314814 | |
| Arm/Group Description | Single 50 milligram (mg) dose of LY3314814 administered orally simultaneously with a single 100 microgram (μg) intravenous (IV) infusion of [13C415N3] LY3314814 over 2 hours on Day 1. | |
All Cause Mortality |
||
| LY3314814 + [13C415N3] LY3314814 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | |
Serious Adverse Events |
||
| LY3314814 + [13C415N3] LY3314814 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| LY3314814 + [13C415N3] LY3314814 | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/8 (37.5%) | |
| Infections and infestations | ||
| Nasopharyngitis | 1/8 (12.5%) | 1 |
| Oral herpes | 1/8 (12.5%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Dermatitis contact | 1/8 (12.5%) | 1 |
Limitations/Caveats
[Not Specified]
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 |
| Clinicaltrials.gov@lilly.com |
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT03222427
Other Study ID Numbers:
- 15993
- I8D-MC-AZEP
- 2017-001181-18
First Posted:
Jul 19, 2017
Last Update Posted:
Oct 31, 2019
Last Verified:
Oct 1, 2019