Phase 1
N=48
Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02201056 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) — 41.7; 33.3; 16.7; 33.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- TAK-935 (Drug); Placebo (Drug)
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) |
41.7; 33.3; 16.7; 33.3; 83.3; 33.3 | — |
| PRIMARY Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose |
16.7; 0; 0; 0; 0; 16.7 | — |
| PRIMARY Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose |
75.0; 100; 66.7; 66.7; 66.7; 66.7 | — |
| PRIMARY Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose |
25.0; 66.7; 83.3; 50.0; 16.7; 33.3 | — |
| SECONDARY Cmax: Maximum Observed Plasma Concentration for TAK-935 |
43.533; 210.150; 571.167; 4551.667; 5080.000; 7953.333 | — |
| SECONDARY AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935 |
33.323; 168.736; 562.660; 5791.561; 7619.088; 13501.049 | — |
| SECONDARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935 |
23.290; 172.430; 621.369; 5809.066; 7660.961; 13541.772 | — |
Summary
The purpose of this study is to characterize the safety and tolerability profile of TAK-935 in healthy participants when administered as a single dose of oral solution at escalating dose levels.
Eligibility Criteria
Inclusion Criteria
- Is a healthy male or female adult who is 19 to 55 years of age inclusive at the time of informed consent.
- Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive at the Screening Visit.
Exclusion Criteria
- Has uncontrolled, clinically significant neurological (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunologic, endocrine disease, or psychiatric disorder, or other abnormality.
- Has a known hypersensitivity to any component of the formulation of TAK-935.
- There is any finding in the participant's medical history, significant results from physical examination, or safety laboratory tests.
Data sourced from ClinicalTrials.gov (NCT02201056). 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.