Phase 1, TAK-648, Single-Rising Dose Study

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind, Placebo- Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single Oral TAK-648 Doses in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684396
• Other study ID #: TAK-648_101
• Secondary ID: U1111-1154-2329
• Status: Completed
• Phase: Phase 1
• First received: February 16, 2016
• Last updated: February 16, 2016
• Start date: September 2014
• Est. completion date: July 2015

Study information

• Verified date: February 2016
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

This is a phase 1, randomized, double-blind, placebo-controlled, single-center, single-dose study in healthy subjects 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 subjects.

The compound being tested in this study is TAK-648. TAK-648 is being tested to find a safe and well-tolerated dose and to assess how TAK-648 is eliminated by the body. This study evaluates side effects and lab results in people who take TAK-648 and is a randomized dose-rising study.

Approximately 40 healthy male and female subjects were planned for enrollment with 8 subjects planned (6 randomized to TAK-648 and 2 randomized to placebo) for each cohort. The study consisted of 5 cohorts.

• TAK-648 will be dosed in 5 sequential cohorts with escalating dose from the lowest dose given in Cohort 1 to higher doses given in the subsequent cohorts)

• Placebo(dummy inactive solution) - this is a solution that looks like the study drug but has no active ingredient This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 45 days. Participants will make multiple visits to the clinic, including one 5-day period of confinement to the clinic. All participants will be contacted by telephone 14 days after the last dose of study drug and on Day 84 (+/-2 days) for a follow-up assessment .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Is a healthy adult male or non-pregnant, non-lactating female.

2. Is aged 18 to 55 years, inclusive.

3. Weighs at least 55 kg (121 lbs) and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive.

4. 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).

5. Has a calculated creatinine clearance >60 mL/min at Screening and Check-in (Day -2).

Exclusion Criteria:

1. Has a known hypersensitivity to any component of the formulation of TAK-648, phosphodiesterase inhibitors or Listerine strips.

2. 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.

3. 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

4. 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.

5. 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.

6. Use of any excluded medications, supplement, or food product outlined in the protocol.

7. Use of new medications during the course of the study including through the Follow-up period.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• TAK-648
TAK-648 Solution
• TAK-648 Placebo
TAK-648 placebo-matching solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who Have at Least One Treatment-Emergent Adverse Event (TEAE)		Day 1 to Day 14	No
Primary	Percentage of Participants who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose		Day 1 to Day 4	No
Primary	Percentage of Participants who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose	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	No
Primary	Percentage of Participants with at Least One Occurrence of Severe Hypoglycemia Post-dose	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	No
Secondary	Cmax: Maximum Observed Plasma Concentration for TAK-648	Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.	Pre-dose and multiple time-points (Up to 72 hours)	No
Secondary	Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648	Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.	Pre-dose and multiple time-points (Up to 72 hours)	No
Secondary	AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648	AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration.	Pre-dose and multiple time-points (Up to 72 hours)	No
Secondary	AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-648	AUC(0-inf) is measure of area under the curve from time 0 to infinity, calculated as AUCt+Clast/?z, where Clast is the last quantifiable concentration	Pre-dose and multiple time-points (Up to 72 hours)	No