A Study to Determine the Bioavailability and Food Effect of a Single TAK-935 Dose in Healthy Participants

Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT02906813
Collaborator
(none)
9
1
3
1.9
4.7

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the relative bioavailability (BA) of 300 milligram (mg) TAK-935 tablets compared to 300 mg of TAK-935 solution and to determine the effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants.

Condition or Disease Intervention/Treatment Phase
  • Drug: TAK-935 Tablets
  • Drug: TAK-935 Oral Solution
Phase 1

Detailed Description

The drug being tested in this study is called TAK-935. The study will look at the relative BA of TAK-935 300 mg tablets compared to a TAK-935 300 mg oral solution and will assess the effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants.

The study will enroll approximately 9 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 3 treatment sequences:

  • TAK-935 (300 mg Tablets Fed + 300 mg Tablets Fasted + 300 mg Solution Fasted)

  • TAK-935 (300 mg Tablets Fasted + 300 mg Solution Fasted + 300 mg Tablets Fed)

  • TAK-935 (300 mg Solution Fasted + 300 mg Tablets Fed + 300 mg Tablets Fasted)

Administration of each dose will be separated by a washout period of at least 3 days. Participants will be asked to take single dose of TAK-935 tablet or oral solution on Day 1 of each Intervention Period.

This single center trial will be conducted in the United States. The overall time to participate in this study is 39 days. Participants will remain confined to the clinic from Day 1 of Intervention Period 1 to Day 3 of Intervention Period 3 and will be contacted by telephone 30 days after last dose of TAK-935 for a follow-up assessment.

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Phase 1 Bioavailability and Food Effect Study to Compare Tablet Versus Solution Formulation and to Assess the Effect of Food on the Bioavailability of a Single TAK-935 Dose in Healthy Subjects
Actual Study Start Date :
Sep 12, 2016
Actual Primary Completion Date :
Oct 12, 2016
Actual Study Completion Date :
Nov 9, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: TAK-935 300 mg (Tablets Fed+Tablets Fasted+Solution Fasted)

TAK-935 300 mg, tablets, orally, 30 minutes after a high-fat meal on Day 1 of Intervention Period 1, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, under fasted state on Day 1 of Intervention Period 2, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 3.

Drug: TAK-935 Tablets
Tablets

Drug: TAK-935 Oral Solution
Oral solution

Experimental: TAK-935 300 mg (Tablets Fasted+Solution Fasted+Tablets Fed

TAK-935 300 mg, tablets, orally under fasted state on Day 1 of Intervention Period 1, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 2, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg tablets, orally, 30 minutes after high-fat meal on Day 1 of Intervention Period 3.

Drug: TAK-935 Tablets
Tablets

Drug: TAK-935 Oral Solution
Oral solution

Experimental: TAK-935 300 mg (Solution Fasted+Tablets Fed+Tablets Fasted)

TAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 1, followed by washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, 30 minutes after a high-fat meal on Day 1 of Intervention Period 2, followed by washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, under fasted state on Day 1 of Intervention Period 3.

Drug: TAK-935 Tablets
Tablets

Drug: TAK-935 Oral Solution
Oral solution

Outcome Measures

Primary Outcome Measures

  1. Cmax: Maximum Observed Plasma Concentration for TAK-935 [Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose]

  2. AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935 [Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose]

  3. AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935 [Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose]

Secondary Outcome Measures

  1. Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) [Baseline up to 30 days after last dose of study drug (Day 39)]

  2. Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose [Baseline up to Day 11]

  3. Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose. [Baseline up to Day 11]

  4. Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose [Baseline up to Day 11]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Weighs at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m^2), inclusive at Screening and Day -2.
Exclusion Criteria:
  1. Has received TAK-935 in a previous clinical study or as a therapeutic agent.

  2. Has a history of any psychiatric disorder as diagnosed utilizing Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria.

  3. Has any lifetime history of drug abuse (defined as any illicit drug use) or any lifetime history of alcohol abuse prior to the screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or a single measure of spirits or 1 small glass of wine.

  4. Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.

  5. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody at Screening or a known history of human immunodeficiency virus infection.

  6. Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-In Day -1. Cotinine test is positive at Screening or Check-In (Day -1).

  7. Has poor peripheral venous access.

  8. Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1 of Period 1.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Glendale California United States

Sponsors and Collaborators

  • Takeda

Investigators

  • Study Director: Medical Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT02906813
Other Study ID Numbers:
  • TAK-935-1005
  • U1111-1177-8044
First Posted:
Sep 20, 2016
Last Update Posted:
Sep 19, 2018
Last Verified:
Jan 1, 2018
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Takeda

Study Results

Participant Flow

Recruitment Details Participants took part in the study at 1 investigative site in the United States from 12 September 2016 to 09 November 2016.
Pre-assignment Detail Healthy participants were enrolled in 1 of the 3 treatment sequences that determined the order of the three treatments received: TAK-935 300 milligram (mg) tablets in fasted state, TAK-935 300 mg tablets in fed state and TAK-935 300 mg solution in fasted state.
Arm/Group Title TAK-935 300 mg: Tablets Fed + Tablets Fasted + Solution Fasted TAK-935 300 mg: Tablets Fasted + Solution Fasted + Tablets Fed TAK 935 300 mg: Solution Fasted + Tablets Fed + Tablets Fasted
Arm/Group Description TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 3. TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 3. TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 3.
Period Title: Intervention Period 1 (3 Days)
STARTED 3 3 3
COMPLETED 3 3 3
NOT COMPLETED 0 0 0
Period Title: Intervention Period 1 (3 Days)
STARTED 3 3 3
COMPLETED 3 3 3
NOT COMPLETED 0 0 0
Period Title: Intervention Period 1 (3 Days)
STARTED 3 3 3
COMPLETED 3 3 3
NOT COMPLETED 0 0 0
Period Title: Intervention Period 1 (3 Days)
STARTED 3 3 3
COMPLETED 3 3 3
NOT COMPLETED 0 0 0
Period Title: Intervention Period 1 (3 Days)
STARTED 3 3 3
COMPLETED 3 3 3
NOT COMPLETED 0 0 0

Baseline Characteristics

Arm/Group Title TAK-935 300 mg: Tablets Fed + Tablets Fasted + Solution Fasted TAK-935 300 mg: Tablets Fasted + Solution Fasted + Tablets Fed TAK 935 300 mg: Solution Fasted + Tablets Fed + Tablets Fasted Total
Arm/Group Description TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 3. TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 3. TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 3. Total of all reporting groups
Overall Participants 3 3 3 9
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
37.3
(7.77)
37.0
(3.00)
35.7
(13.58)
36.7
(8.00)
Sex: Female, Male (Count of Participants)
Female
1
33.3%
0
0%
1
33.3%
2
22.2%
Male
2
66.7%
3
100%
2
66.7%
7
77.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
Black or African American
3
100%
2
66.7%
0
0%
5
55.6%
White
0
0%
1
33.3%
2
66.7%
3
33.3%
More than one race
0
0%
0
0%
1
33.3%
1
11.1%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
Region of Enrollment (Count of Participants)
United States
3
100%
3
100%
3
100%
9
100%
Height (centimeter (cm)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeter (cm)]
172.0
(6.24)
171.0
(2.00)
170.3
(1.53)
171.1
(3.44)
Weight (kilogram (kg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram (kg)]
83.17
(10.970)
78.20
(1.311)
71.50
(10.096)
77.62
(9.039)
Body Mass Index (BMI) (kilogram per square meter (kg/m^2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram per square meter (kg/m^2)]
28.01
(1.784)
26.75
(0.889)
24.62
(3.295)
26.46
(2.430)
Smoking Classification (Count of Participants)
Never smoked
2
66.7%
2
66.7%
3
100%
7
77.8%
Ex-smoker
1
33.3%
1
33.3%
0
0%
2
22.2%
No Alcohol Consumption (Count of Participants)
Count of Participants [Participants]
3
100%
3
100%
3
100%
9
100%
No Xanthine/Caffeine Consumption (Count of Participants)
Count of Participants [Participants]
3
100%
3
100%
3
100%
9
100%
Female Reproductive Status (Count of Participants)
Postmenopausal
0
0%
0
0%
1
33.3%
1
11.1%
Having childbearing potential
1
33.3%
0
0%
0
0%
1
11.1%
Not applicable
2
66.7%
3
100%
2
66.7%
7
77.8%

Outcome Measures

1. Primary Outcome
Title Cmax: Maximum Observed Plasma Concentration for TAK-935
Description
Time Frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

Outcome Measure Data

Analysis Population Description
The pharmacokinetic (PK) set included all participants who were enrolled, received study drug and had at least 1 measurable plasma concentration for either TAK-935 or its metabolite (M-I).
Arm/Group Title TAK-935 300 mg Tablets Fed TAK-935 300 mg Tablets Fasted TAK-935 300 mg Solution Fasted
Arm/Group Description TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3. TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3. TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
Measure Participants 9 9 9
Mean (Standard Deviation) [nanogram per milliliter (ng/mL)]
477.000
(298.0705)
1150.889
(710.5940)
1882.000
(1250.7022)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAK-935 300 mg Tablets Fasted, TAK-935 300 mg Solution Fasted
Comments Analysis of variance (ANOVA) was performed on natural logarithms of TAK-935 Cmax with fixed factors of sequence, period and regimen, and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative bioavailability (BA) of TAK-935 tablet to solution. Point estimate and 90 percent (%) confidence interval (CI) in original scale were obtained by exponentiation of differences in natural-log scale.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.079
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Least Square (LS) Mean Ratio
Estimated Value 0.631
Confidence Interval (2-Sided) 90%
0.411 to 0.969
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAK-935 300 mg Tablets Fed, TAK-935 300 mg Tablets Fasted
Comments ANOVA was performed on natural logarithms of TAK-935 Cmax with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% confidence interval in original scale were obtained by exponentiation of differences in natural-log scale.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.002
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter LS Mean Ratio
Estimated Value 0.403
Confidence Interval (2-Sided) 90%
0.262 to 0.618
Parameter Dispersion Type:
Value:
Estimation Comments
2. Primary Outcome
Title AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935
Description
Time Frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

Outcome Measure Data

Analysis Population Description
The PK set included all participants who were enrolled, received study drug and had at least 1 measurable plasma concentration for either TAK-935 or its M-I.
Arm/Group Title TAK-935 300 mg Tablets Fed TAK-935 300 mg Tablets Fasted TAK-935 300 mg Solution Fasted
Arm/Group Description TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3. TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3. TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
Measure Participants 9 9 9
Mean (Standard Deviation) [nanogram hours per milliliter (ng*hr/mL)]
1170.954
(386.1425)
1328.482
(496.8168)
1601.806
(711.7143)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAK-935 300 mg Tablets Fasted, TAK-935 300 mg Solution Fasted
Comments ANOVA was performed on natural logarithms of TAK-935 AUCt with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 tablet to solution. Point estimate and 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.146
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter LS Mean Ratio
Estimated Value 0.850
Confidence Interval (2-Sided) 90%
0.706 to 1.024
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAK-935 300 mg Tablets Fed, TAK-935 300 mg Tablets Fasted
Comments ANOVA was performed on natural logarithms of TAK-935 AUCt with factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.281
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter LS Mean Ratio
Estimated Value 0.889
Confidence Interval (2-Sided) 90%
0.738 to 1.070
Parameter Dispersion Type:
Value:
Estimation Comments
3. Primary Outcome
Title AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935
Description
Time Frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

Outcome Measure Data

Analysis Population Description
The PK analysis set where data on Day 1 was available. The PK set included all participants who were enrolled, received study drug and had at least 1 measurable plasma concentration for either TAK-935 or its M-I.
Arm/Group Title TAK-935 300 mg Tablets Fed TAK-935 300 mg Tablets Fasted TAK-935 300 mg Solution Fasted
Arm/Group Description TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3. TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3. TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
Measure Participants 9 8 8
Mean (Standard Deviation) [ng*hr/mL]
1182.641
(385.6485)
1369.963
(523.2334)
1564.307
(743.3798)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAK-935 300 mg Tablets Fasted, TAK-935 300 mg Solution Fasted
Comments ANOVA was performed on natural logarithms of TAK-935 AUC∞ with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 tablet to solution. Point estimate and 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.191
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter LS Mean Ratio
Estimated Value 0.842
Confidence Interval (2-Sided) 90%
0.676 to 1.050
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAK-935 300 mg Tablets Fed, TAK-935 300 mg Tablets Fasted
Comments ANOVA was performed on natural logarithms of TAK-935 AUC∞ with factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.355
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter LS Mean Ratio
Estimated Value 0.894
Confidence Interval () 90%
0.726 to 1.100
Parameter Dispersion Type:
Value:
Estimation Comments
4. Secondary Outcome
Title Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Description
Time Frame Baseline up to 30 days after last dose of study drug (Day 39)

Outcome Measure Data

Analysis Population Description
The safety analysis set included all participants who were enrolled and received study drug.
Arm/Group Title TAK-935 300 mg Tablets Fed TAK-935 300 mg Tablets Fasted TAK-935 300 mg Solution Fasted
Arm/Group Description TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3. TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3. TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
Measure Participants 9 9 9
Number [percentage of participants]
0
0%
22.2
740%
0
0%
5. Secondary Outcome
Title Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Description
Time Frame Baseline up to Day 11

Outcome Measure Data

Analysis Population Description
The safety analysis set included all participants who were enrolled and received study drug.
Arm/Group Title TAK-935 300 mg Tablets Fed TAK-935 300 mg Tablets Fasted TAK-935 300 mg Solution Fasted
Arm/Group Description TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3. TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3. TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
Measure Participants 9 9 9
Number [percentage of participants]
0
0%
0
0%
0
0%
6. Secondary Outcome
Title Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose.
Description
Time Frame Baseline up to Day 11

Outcome Measure Data

Analysis Population Description
The safety analysis set included all participants who were enrolled and received study drug.
Arm/Group Title TAK-935 300 mg Tablets Fed TAK-935 300 mg Tablets Fasted TAK-935 300 mg Solution Fasted
Arm/Group Description TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3. TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3. TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
Measure Participants 9 9 9
Number [percentage of participants]
22.2
740%
0
0%
33.3
1110%
7. Secondary Outcome
Title Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
Description
Time Frame Baseline up to Day 11

Outcome Measure Data

Analysis Population Description
The safety analysis set included all participants who were enrolled and received study drug.
Arm/Group Title TAK-935 300 mg Tablets Fed TAK-935 300 mg Tablets Fasted TAK-935 300 mg Solution Fasted
Arm/Group Description TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3. TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3. TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
Measure Participants 9 9 9
Number [percentage of participants]
33.3
1110%
33.3
1110%
55.6
1853.3%

Adverse Events

Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 39) after the last dose of study drug
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Arm/Group Title TAK-935 300 mg Tablets Fed TAK-935 300 mg Tablets Fasted TAK-935 300 mg Solution Fasted
Arm/Group Description TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3. TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3. TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
All Cause Mortality
TAK-935 300 mg Tablets Fed TAK-935 300 mg Tablets Fasted TAK-935 300 mg Solution Fasted
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/9 (0%) 0/9 (0%) 0/9 (0%)
Serious Adverse Events
TAK-935 300 mg Tablets Fed TAK-935 300 mg Tablets Fasted TAK-935 300 mg Solution Fasted
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/9 (0%) 0/9 (0%) 0/9 (0%)
Other (Not Including Serious) Adverse Events
TAK-935 300 mg Tablets Fed TAK-935 300 mg Tablets Fasted TAK-935 300 mg Solution Fasted
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/9 (0%) 2/9 (22.2%) 0/9 (0%)
Gastrointestinal disorders
Flatulence 0/9 (0%) 1/9 (11.1%) 0/9 (0%)
Nervous system disorders
Headache 0/9 (0%) 1/9 (11.1%) 0/9 (0%)
Skin and subcutaneous tissue disorders
Dermatitis contact 0/9 (0%) 1/9 (11.1%) 0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.

Results Point of Contact

Name/Title Medical Director
Organization Takeda
Phone +1-877-825-3327
Email trialdisclosures@takeda.com
Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT02906813
Other Study ID Numbers:
  • TAK-935-1005
  • U1111-1177-8044
First Posted:
Sep 20, 2016
Last Update Posted:
Sep 19, 2018
Last Verified:
Jan 1, 2018