Phase 1
N=47
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-137 in Healthy Participants
Dose Finding Study
Bottom Line
View on ClinicalTrials.gov: NCT02334982 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event — 0; 16.7; 0; 16.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- TAK-137 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event |
0; 16.7; 0; 16.7; 50.0; 33.3 | — |
| PRIMARY Percentage of Participants With Abnormal Safety Laboratory Findings |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Markedly Abnormal Vital Sign Measurements |
0; 16.7; 0; 16.7; 0; 8.3 | — |
| SECONDARY Cmax: Maximum Observed Plasma Concentration for TAK-137 |
38.8; 68.90; 121.1; 61.1; 9.0; 206.1 | — |
| SECONDARY Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137 |
2.00; 3.00; 3.00; 2.50; 2.00; 2.50 | — |
| SECONDARY AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-137 |
405; 1668; 3012; 1191; 94; 5346 | — |
| SECONDARY AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-137 |
408; 1696; 3135; 1198; 97; 5353 | — |
| SECONDARY Terminal Elimination Half-life (T1/2) for TAK-137_101 |
6.65; 12.66; 13.60; 15.77; 8.54; 13.09 | — |
| SECONDARY Apparent Clearance (CL/F) for TAK-137_101 |
5.22; 3.66; 5.23; 5.91; 6.26; 7.19 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) for TAK-137_101 |
48.57; 62.26; 81.23; 134.49; 62.85; 110.48 | — |
| SECONDARY Total Amount of Drug (TAK-137) Excreted in Urine From Time 0 to Time t (Ae[0-t]) |
0.0039; 0.0164; 0.0470; 0.0192; 0.0002; 0.0585 | — |
| SECONDARY Fraction of TAK-137 Excreted in Urine (Fe) |
0.19; 0.33; 0.47; 0.38; 0.04; 0.29 | — |
| SECONDARY Renal Clearance (CLr) for TAK-137 |
0.0093; 0.0094; 0.0138; 0.0164; 0.0031; 0.0117 | — |
Summary
The purpose of this study is to characterize the safety and tolerability profile of TAK-137 when administered as a single dose of tablets at escalating dose levels in healthy participants.
Eligibility Criteria
Inclusion Criteria
- Is a healthy male or non-pregnant, non-lactating female adult who is 18 to 55 years of age inclusive at the time of informed consent and first study medication dose.
- Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30.0 kg/m^2, inclusive at Screening.
- Is able to comply with the protocol and is willing to sign the informed consent prior to undergoing any study-related procedures.
Exclusion Criteria
- Has a known hypersensitivity to any component of the formulation of TAK-137.
- Has a medical condition such as mental retardation that can cause cognitive impairment.
- Has a risk of suicide according to the Investigator's clinical judgment (eg, per Columbia-Suicide Severity Rating Scale [C-SSRS] or has made a suicide attempt in the previous 6 months).
- Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash.
- There is any finding in the participant's medical history, physical examination, or safety laboratory tests (including safety electroencephalogram [EEG]) giving reasonable suspicion of a disease that would contraindicate taking TAK-137, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.
- Has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table.
Data sourced from ClinicalTrials.gov (NCT02334982). 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.