drugset / Trial / NCT02316912
First in Man Evaluation of Single and Multiple Doses of Oral ATX2417
RandomizedParallel-groupDouble-blind
Summary
First in man evaluation of single and multiple doses of compound ATX2417 in healthy male volunteers. A double blind placebo controlled parallel group ascending dose design; up to five dose levels for the single dose and up to two dose levels for the multiple dose (8 days of dosing). Subjects will be screened to assure normal health prior to inclusion in the trial and will be monitored for safety (adverse events, vital signs, ECGs, safety labs) and pharmacokinetic profile. A fasted/fed comparison will also be included in the single ascending dose part of the trial.
Timeline
- Start
- 2015-02
- Primary completion
- 2016-04
- Completion
- 2016-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ATX2417 | Unknown | 2 mg | Oral |
| Comparator | ATX2417 | Unknown | 5 mg | Oral |
| Comparator | ATX2417 | Unknown | 20 mg | Oral |