Study to Evaluate Safety, Tolerability and PK of C-10355... | NCT02392702 | Trialant

Study to Evaluate Safety, Tolerability and PK of C-10355... | NCT02392702 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
C-10355, 25 mg	Active Comparator	single oral dose.	Drug: C-10355
C-10358, 25 mg	Active Comparator	single oral dose.	Drug: C-10358
C-10355 or C-10358, 75 mg	Active Comparator	single oral dose.	Drug: C-10355 Drug: C-10358
C-10355 or C-10358, 150 mg	Active Comparator	single oral dose.	Drug: C-10355 Drug: C-10358
Kalydeco, 150 mg	Active Comparator	single oral dose.	Drug: Kalydeco
C-10355 or C-10358, 300 mg	Active Comparator	single oral dose.	Drug: C-10355 Drug: C-10358

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	adverse events categorized by body system and MedDRA term	24 hours
Pharmacokinetic Profile	Measure exposure of test articles using area under the concentration time curve (AUC), maximum concentration (Cmax), half life (T 1/2)	96 hours

Contacts/Locations Module