Phase 1
N=39
Phase 1, TAK-648, Single-Rising Dose Study
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02684396 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE) — 0; 50.0; 16.7; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- TAK-648 (Drug); TAK-648 Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE) |
0; 50.0; 16.7; 0; 20.0; 30.0 | — |
| PRIMARY Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose |
33.3; 16.7; 33.3; 33.3; 20.0; 40.0 | — |
| PRIMARY Percentage of Participants With at Least One Occurrence of Severe Hypoglycemia Post-dose |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Cmax: Maximum Observed Plasma Concentration for TAK-648 |
0.619; 2.330; 3.997; 11.845; 11.712 | — |
| SECONDARY Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648 |
1.000; 1.500; 1.000; 1.000; 1.000 | — |
| SECONDARY AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 |
4.452; 16.614; 27.927; 75.280; 92.661 | — |
| SECONDARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648 |
4.585; 16.813; 28.266; 75.774; 93.840 | — |
Summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of TAK-648 when administered as a single oral dose of TAK-648 solution at escalating dose levels in healthy participants.
Eligibility Criteria
Inclusion Criteria
- Is a healthy adult male or non-pregnant, non-lactating female.
- Is aged 18 to 55 years, inclusive.
- Weighs at least 55 kg (121 lbs) and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive.
- Has a systolic blood pressure >90 and ≤150 mm Hg and a diastolic blood pressure of >60 and ≤90 mm Hg at Screening and at Check-in (Day -2).
- Has a calculated creatinine clearance >60 mL/min at Screening and Check-in (Day -2).
Exclusion Criteria
- Has a known hypersensitivity to any component of the formulation of TAK-648, phosphodiesterase inhibitors or Listerine strips.
- Has significant medical histories or currently uncontrolled clinical conditions, which may not be safe for participant to participate in the study, may impact the participant's ability to participate in the study; may influence absorption of the study drug, or may potentially confound the study results.
- Has a history of persistent, chronic or intermittent nausea, vomiting, or diarrhea or had a current or recent (within 6 months) gastrointestinal disease that would influence the absorption of drugs
- Has a diagnosis of major depression, bipolar disorder, or anxiety disorders or received any medication to treat any psychological disorders within 1 year prior to Screening.
- Has abnormal laboratory values that suggest a clinically significant underlying disease or has the following laboratory abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2.5 times the upper limits of normal.
- Use of any excluded medications, supplement, or food product outlined in the protocol.
- Use of new medications during the course of the study including through the Follow-up period.
Data sourced from ClinicalTrials.gov (NCT02684396). 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.