- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02684396
Phase 1, TAK-648, Single-Rising Dose Study
A Phase 1, Randomized, Double-Blind, Placebo- Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single Oral TAK-648 Doses in Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was a phase 1, randomized, double-blind, placebo-controlled, single-center, single-dose study in healthy participants. The study is the first TAK-648 study in humans and is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of TAK-648 to healthy participants.
The compound being tested in this study is TAK-648. TAK-648 is being tested to find a safe and well-tolerated single dose.
This study measured how much of the study drug got into the blood stream and how long it took the body to get rid of it. Information about any side effects that may have occurred was also collected. This study was a randomized dose-rising study which means that the first group of research participants was assigned by chance to receive either the study drug or placebo. Placebo is a solution that looks like the study drug but has no active ingredient. The lowest dose of the study drug or placebo was given to the 1st group of participants (1st cohort) and a higher dose was given to the next group until all the doses of the study drug were tested. TAK-648 was dosed in 5 sequential cohorts with escalating doses from the lowest dose given in Cohort 1 to higher doses given in the subsequent cohort. Doses could be adjusted based on available safety, tolerability, and pharmacokinetic (PK) data.
Approximately 40 healthy male and female participants were planned for enrollment with 8 subjects planned (6 randomized to TAK-648 and 2 randomized to placebo) for each cohort. The study included 5 cohorts.
This single-center trial was conducted in the United States. The overall time to participate in this study was up to 45 days. Participants made multiple visits to the clinic, including one 5-day period of confinement to the clinic. All participants were contacted by telephone 14 days after the last dose of study drug and on Day 84 (+/-2 days) for a follow-up assessment.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1: TAK-648 0.05 mg
TAK-648 0.05 mg, solution, orally, once on Day 1.
|
TAK-648 Solution
|
Experimental: Cohort 2: TAK-648 0.15 mg
TAK-648 0.15 mg, solution, orally, once on Day 1.
|
TAK-648 Solution
|
Experimental: Cohort 3: TAK-648 0.35 mg
TAK-648 0.35 mg, solution, orally, once on Day 1.
|
TAK-648 Solution
|
Experimental: Cohort 4: TAK-648 0.7 mg
TAK-648 0.7 mg, solution, orally, once on Day 1.
|
TAK-648 Solution
|
Experimental: Cohort 5: TAK-648 0.85 mg
TAK-648 0.85 mg, solution, orally, once on Day 1.
|
TAK-648 Solution
|
Placebo Comparator: Cohort 1-5: Placebo
TAK-648 placebo-matching solution, orally, once on Day 1.
|
TAK-648 placebo-matching solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE)
Time Frame: Day 1 to Day 14
|
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
|
Day 1 to Day 14
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose
Time Frame: Day 1 to Day 4
|
The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry, hematology and urinalysis) collected throughout study.
|
Day 1 to Day 4
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose
Time Frame: Day 1 to Day 4
|
Vital signs will include body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), respiration rate and pulse (bpm).
|
Day 1 to Day 4
|
Percentage of Participants With at Least One Occurrence of Severe Hypoglycemia Post-dose
Time Frame: Day 1 to Day 4
|
Severe hypoglycemia is defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
|
Day 1 to Day 4
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax: Maximum Observed Plasma Concentration for TAK-648
Time Frame: Multiple time-points (up to 72 hours) post-dose
|
Multiple time-points (up to 72 hours) post-dose
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648
Time Frame: Multiple time-points (up to 72 hours) post-dose
|
Multiple time-points (up to 72 hours) post-dose
|
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648
Time Frame: Multiple time-points (up to 72 hours) post-dose
|
Multiple time-points (up to 72 hours) post-dose
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648
Time Frame: Multiple time-points (up to 72 hours) post-dose
|
Multiple time-points (up to 72 hours) post-dose
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TAK-648_101
- U1111-1154-2329 (Other Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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