Phase 1
Completed N=24
A Study to Assess the Relative Bioavailability and to Assess the Effect of Food on the Bioavailability of a TAK-648 Tablet in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT02480439 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcomePrimary: Cmax: Maximum Observed Plasma Concentration for TAK-648 — 4.504; 4.707; 5.185 mg/mL
Summary
The purpose of this study is to assess the relative bioavailability of a TAK-648 tablet compared with a TAK-648 oral solution, and to assess the effect of food on the bioavailability of a TAK-648 tablet in healthy participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration for TAK-648 |
4.504; 4.707; 5.185 | — |
| PRIMARY AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 |
34.855; 34.526; 34.916 | — |
| PRIMARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648 |
35.241; 34.922; 35.353 | — |
| SECONDARY Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) |
17.4; 8.7; 0.0 | — |
| SECONDARY Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose |
4.3; 4.3; 0 | — |
| SECONDARY Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose |
39.1; 47.8; 60.9 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male or female aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
- Weighs at least 50 kilogram (kg) (110 pounds [lbs]) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m^2), inclusive at Screening.
- Has systolic blood pressure greater than (>) 90 and less than or equal to ( 60 and 60 milliliter per minute (mL/min) at Screening and Check-in (Day -1) of Period 1.
- Male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
- Female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent and throughout the duration of the study and for 12 weeks after the last dose.
Exclusion Criteria
- Has received any investigational compound within 30 days prior to the first dose of study medication.
- Has received TAK-648 in a previous clinical study or as a therapeutic agent.
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
- Has any significant medical histories or currently uncontrolled clinical conditions, which may render it unsafe for participant to participate in the study, may impact the ability of the participant to participate in the study, or may potentially confound the study results.
- Has a history of significant gastrointestinal (GI) disorders manifested with persistent, chronic, or intermittent nausea, vomiting, or diarrhea, or has a current or recent (within 6 months) GI disease that would influence the absorption of drugs.
- Has diagnosis of major depression, bipolar disorder, or anxiety disorders, or has received any medication to treat any psychological disorders within 1 year.
- Has a risk of suicide according to the investigator's clinical judgment per Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or has made a suicide attempt in the past 6 months prior to screening.
- Has known hypersensitivity to any component of the formulation of TAK-648, or to a phosphodiesterase type 4 (PDE4) inhibitor (example, roflumilast).
- Has taken any excluded medication, supplements, or food products during the time periods listed in the Prohibited Medications table.
- Has abnormal Screening or Check-in (Day -1) of Period 1 laboratory values that suggest a clinically significant underlying disease or participant has the following laboratory abnormalities: Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2.5* upper limit of normal (ULN).
Data sourced from ClinicalTrials.gov (NCT02480439). 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.