Study to Evaluate Safety, Tolerability and PK of C-10355 and C-10358 in Healthy Subjects

A Two-Part Open-Label, Randomized, Sequential, Crossover, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of C-10355 and C-10358 in Healthy Volunteers, With a PK Comparison to Kalydeco®

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02392702

Enrollment

Registered

2015-03-19

Start date

2015-03-31

Completion date

2015-09-30

Last updated

2015-09-23

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

Conditions

Healthy

Keywords

Subjects, Safety/Efficacy Study, Randomized, Open Label

Brief summary

This two-part study will assess, in healthy volunteers, under both fasted and fed conditions, and in a sequential manner, the safety, tolerability and pharmacokinetics (PK) profile of single doses of C-10355 and C-10358 and single ascending doses of the selected compound compared to a single dose of Kalydeco®.

Interventions

DRUGC-10355

DRUGC-10358

DRUGKalydeco

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

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	24 hours	adverse events categorized by body system and MedDRA term
Pharmacokinetic Profile	96 hours	Measure exposure of test articles using area under the concentration time curve (AUC), maximum concentration (Cmax), half life (T 1/2)

Countries

Australia

Outcome results

None listed

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