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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02599792

Enrollment

Registered

2015-11-09

Start date

2015-11-30

Completion date

2016-04-30

Last updated

2016-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety and Pharmacokinetics

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.

Detailed 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.

Interventions

DRUGCTP-656

DRUGPlacebo for CTP-656

DRUGKalydeco

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	7 days	adverse events categorized by body system and MedDRA term
Measure exposure of test articles using area under the concentration time curve (AUC)	96 hours	—

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026