Phase 1
Completed N=9
A Study to Determine the Bioavailability and Food Effect of a Single TAK-935 Dose in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT02906813 ↗
Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Cmax: Maximum Observed Plasma Concentration for TAK-935 — 477.000; 1150.889; 1882.000 nanogram per milliliter (ng/mL) — p=0.079
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration for TAK-935 |
477.000; 1150.889; 1882.000 | 0.079 |
| PRIMARY AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935 |
1170.954; 1328.482; 1601.806 | 0.146 |
| PRIMARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935 |
1182.641; 1369.963; 1564.307 | 0.191 |
| SECONDARY Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) |
0; 22.2; 0 | — |
| SECONDARY Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose |
0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose. |
22.2; 0; 33.3 | — |
| SECONDARY Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose |
33.3; 33.3; 55.6 | — |
Eligibility Criteria
Inclusion Criteria
- 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
- Has received TAK-935 in a previous clinical study or as a therapeutic agent.
- Has a history of any psychiatric disorder as diagnosed utilizing Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria.
- 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.
- Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
- 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.
- 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).
- Has poor peripheral venous access.
- 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.
Data sourced from ClinicalTrials.gov (NCT02906813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.