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

NCT02684396 | Completed Phase 1 Results

• 2 other identifiers: TAK-648_101U1111-1154-2329
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Volunteers

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (4)

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

  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

  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

  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

  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 Outcomes (4)

• Cmax: Maximum Observed Plasma Concentration for TAK-648

  Multiple time-points (up to 72 hours) post-dose

• Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648

  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

  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

  Multiple time-points (up to 72 hours) post-dose

Study Arms (6)

Cohort 1: TAK-648 0.05 mg

EXPERIMENTAL

TAK-648 0.05 mg, solution, orally, once on Day 1.

Drug: TAK-648

Cohort 2: TAK-648 0.15 mg

EXPERIMENTAL

TAK-648 0.15 mg, solution, orally, once on Day 1.

Drug: TAK-648

Cohort 3: TAK-648 0.35 mg

EXPERIMENTAL

TAK-648 0.35 mg, solution, orally, once on Day 1.

Drug: TAK-648

Cohort 4: TAK-648 0.7 mg

EXPERIMENTAL

TAK-648 0.7 mg, solution, orally, once on Day 1.

Drug: TAK-648

Cohort 5: TAK-648 0.85 mg

EXPERIMENTAL

TAK-648 0.85 mg, solution, orally, once on Day 1.

Drug: TAK-648

Cohort 1-5: Placebo

PLACEBO COMPARATOR

TAK-648 placebo-matching solution, orally, once on Day 1.

Drug: TAK-648 Placebo

Interventions

TAK-648 DRUG

TAK-648 Solution

Cohort 1: TAK-648 0.05 mg; Cohort 2: TAK-648 0.15 mg; Cohort 3: TAK-648 0.35 mg; Cohort 4: TAK-648 0.7 mg; Cohort 5: TAK-648 0.85 mg

TAK-648 Placebo DRUG

TAK-648 placebo-matching solution

Cohort 1-5: Placebo

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Results Point of Contact

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

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 18, 2016
• Study Start: August 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 13, 2016
• Results First Posted: July 13, 2016

Record last verified: 2016-04