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

Healthy Clinical Trial

Official title:

A Two-Part Phase 1 Healthy Volunteer Study: A Crossover Comparison of CTP-656 Solid Dose Formulation vs. Kalydeco® and a Double-Blind, Placebo-Controlled, Ascending Multiple Dose Evaluation of CTP-656

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02599792
• Other study ID #: CP656.1002
• Status: Completed
• Phase: Phase 1
• First received: November 5, 2015
• Last updated: April 29, 2016
• Start date: November 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

This two-part study will assess in healthy male and female subjects a solid oral dose formulation of CTP-656 vs. Kalydeco® and the safety, tolerability and pharmacokinetic profiles of escalating CTP-656 solid oral doses following 7 days of dosing. In Part B, three doses of CTP-656 ranging from 75 mg up to 300 mg per day will be studied.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• CTP-656

• Placebo for CTP-656

• Kalydeco

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Concert Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	adverse events categorized by body system and MedDRA term	7 days	Yes
Primary	Measure exposure of test articles using area under the concentration time curve (AUC)		96 hours	No