NCT02680249

Brief Summary

Three way crossover study to assess the bioavailability of 656 under fed and fasted conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

2 months

First QC Date

February 3, 2016

Last Update Submit

April 29, 2016

Conditions

Healthy

Keywords

Safety, Bioavailability and Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Measurement of CTP-656 in plasma under fed and fasted conditions

    Geometric mean ratio of moderate-fat versus low-fat or fasted

    96 hours

Study Arms (3)

CTP-656 Fed, low fat

EXPERIMENTAL

Single dose of CTP-656 150 mg administered after a low-fat breakfast

Drug: CTP-656

CTP-656 Fasted

EXPERIMENTAL

Single dose of CTP-656 150 mg administered fasted

Drug: CTP-656

CTP-656 Fed, high fat

EXPERIMENTAL

Single dose of CTP-656 150 mg administered after a moderate-fat breakfast

Drug: CTP-656

Interventions

CTP-656DRUG
CTP-656 FastedCTP-656 Fed, high fatCTP-656 Fed, low fat

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults between 18 and 50 years of age, inclusive
  • Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive, at screening

You may not qualify if:

  • History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal (including nephrolithiasis), hepatic, including history of Gilbert's syndrome or gastrointestinal (GI) conditions
  • PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcF interval \> 450 msec obtained at screening visit or prior to the first dose of study drug
  • Liver function tests greater than the upper limit of normal.
  • Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening
  • Urinalysis positive for greater than trace blood, protein or glucose
  • A positive screen for alcohol, drugs of abuse, or tobacco use.
  • Inability to comply with dietary restrictions during study participation.
  • Donation or blood collection or acute loss of blood prior to screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, Australia

Location

Study Officials

  • Lana Pilja

    Concert Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 11, 2016

Study Start

February 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 2, 2016

Record last verified: 2016-04

Locations

AU(1)