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

NCT02480439 | Completed Phase 1 Results

• 2 other identifiers: TAK-648-1003U1111-1170-0503
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

• Cmax: Maximum Observed Plasma Concentration for TAK-648

  Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period

• AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648

  Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period

• AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648

  Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period

Secondary Outcomes (3)

• Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)

  First dose of study drug to 30 days after the last dose of study drug (Up to Day 47)

• Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose

  First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)

• Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose

  First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)

Study Arms (3)

TAK-648 Sequence ABC

EXPERIMENTAL

Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 3.

Drug: TAK-648 Tablet; Drug: TAK-648 Oral Solution

TAK-648 Sequence BCA

EXPERIMENTAL

Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 3.

Drug: TAK-648 Tablet; Drug: TAK-648 Oral Solution

TAK-648 Sequence CAB

EXPERIMENTAL

Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, after a high fat meal, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.

Drug: TAK-648 Tablet; Drug: TAK-648 Oral Solution

Interventions

TAK-648 Tablet DRUG

Tak-648 tablet

TAK-648 Sequence ABC; TAK-648 Sequence BCA; TAK-648 Sequence CAB

TAK-648 Oral Solution DRUG

TAK-648 oral solution

TAK-648 Sequence ABC; TAK-648 Sequence BCA; TAK-648 Sequence CAB

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 (\<=) 150 millimeter of mercury (mmHg) and diastolic blood pressure \>60 and \<=90 mm Hg at Screening and at Check-in (Day -1) of Period 1. If out of range, may be repeated once for eligibility determination within a maximum of 5 minutes.
• Has a calculated creatinine clearance \>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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Austin, Texas, United States

Location

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: June 24, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 31, 2016
• Results First Posted: August 31, 2016

Record last verified: 2016-07

Locations

US (1)