Healthy Volunteer Solid Oral Dose and Multiple Ascending Dose Evaluation of CTP-656

NCT02599792 | Completed Phase 1

• 1 other identifier: CP656.1002
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Two-part study to assess CTP-656 dosed as a solid oral dosage form versus Kalydeco and multiple-ascending doses of CTP-656 dosed for 7 days.

Conditions

Healthy

Keywords

Safety and Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  adverse events categorized by body system and MedDRA term

  7 days

• Measure exposure of test articles using area under the concentration time curve (AUC)

  96 hours

Study Arms (5)

CTP-656, 150 mg

EXPERIMENTAL

Single Oral Dose

Drug: CTP-656

Kalydeco, 150 mg

ACTIVE COMPARATOR

Single oral dose

Drug: Kalydeco

CTP-656, 75 mg or matching placebo

EXPERIMENTAL

Subjects will be administered 75 mg CTP-656 for 7 days.

Drug: CTP-656; Drug: Placebo for CTP-656

CTP-656, 150 mg or matching placebo

EXPERIMENTAL

Subjects will be administered 150 mg CTP-656 for 7 days.

Drug: CTP-656; Drug: Placebo for CTP-656

CTP-656, high dose or matching placebo

EXPERIMENTAL

Subjects will be administered up to 300 mg CTP-656 for 7 days.

Drug: CTP-656; Drug: Placebo for CTP-656

Interventions

CTP-656 DRUG

CTP-656, 150 mg; CTP-656, 150 mg or matching placebo; CTP-656, 75 mg or matching placebo; CTP-656, high dose or matching placebo

Placebo for CTP-656 DRUG

CTP-656, 150 mg or matching placebo; CTP-656, 75 mg or matching placebo; CTP-656, high dose or matching placebo

Kalydeco DRUG

Kalydeco, 150 mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 food and beverage restrictions during study participation.
• Donation or blood collection or acute loss of blood prior to screening.

Sponsors & Collaborators

• Concert Pharmaceuticals: lead

Study Sites (1)

Unknown Facility

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Interventions

ivacaftor

Study Officials

• Lana Pilja

  Concert Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 9, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 2, 2016

Record last verified: 2016-04

Locations

AU (1)