drugset / Trial / NCT02392702
Study to Evaluate Safety, Tolerability and PK of C-10355 and C-10358 in Healthy Subjects
RandomizedCrossoverOpen-labelBasic science
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®.
Timeline
- Start
- 2015-03
- Primary completion
- 2015-06
- Completion
- 2015-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | C-10355 | Unknown | 25 mg | Oral |
| Comparator | C-10355 | Unknown | 75 mg | Oral |
| Comparator | C-10355 | Unknown | 150 mg | Oral |
| Comparator | C-10355 | Unknown | 300 mg | Oral |
| Comparator | C-10358 | Unknown | 25 mg | Oral |
| Comparator | C-10358 | Unknown | 75 mg | Oral |
| Comparator | C-10358 | Unknown | 150 mg | Oral |
| Comparator | C-10358 | Unknown | 300 mg | Oral |
| Comparator | Ivacaftor | Other / unclassified | 150 mg | Oral |
Indications
No indication recorded.