Trials / Terminated
TerminatedNCT04452006
A Study in Healthy Subjects to Investigate the Safety and Tolerability of ACT- 541478 as Well as What ACT-541478 Does to the Body and the Way the Body Takes up, Distributes, and Gets Rid of ACT-541478
Single-center, Double-blind, Randomized, Placebo-controlled, Three-part, First-in-human, Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-541478 in Healthy Subjects
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Idorsia Pharmaceuticals Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
A study in healthy subjects to investigate the safety and tolerability of ACT-541478 as well as what ACT-541478 does to the body and the way the body takes up, distributes, and gets rid of of ACT-541478
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ACT-541478 10 mg | ACT-541478 will be provided in HPMC capsules for oral administration at a dose strength of 10 mg. |
| DRUG | ACT-541478 30 mg | ACT-541478 will be provided in HPMC capsules for oral administration at a dose strength of 10 mg. |
| DRUG | ACT-541478 100 mg | ACT-541478 will be provided in HPMC capsules for oral administration at a dose strength of 50 mg. |
| DRUG | ACT-541478 300 mg | ACT-541478 will be provided in HPMC capsules for oral administration at dose strengths of 50 mg and 250 mg. |
| DRUG | ACT-541478 1000 mg | ACT-541478 will be provided in HPMC capsules for oral administration at a dose strength of 250 mg. |
| DRUG | ACT-541478 high or low dose (or placebo) | Cross-over design: ACT-541478 will be provided in HPMC capsules for oral administration at high or low dose strengths (to be defined after completion of Part A). |
| DRUG | ACT-541478 dose E1 | E1 is a dose level that has been investigated and well tolerated in the adult dose level groups C1 to C3. ACT-541478 will be provided in HPMC capsules for oral administration at dose strengths of 10, 50, and 250 mg. |
| DRUG | Matching placebo | Matching placebo will be provided in HPMC capsules for oral administration. |
Timeline
- Start date
- 2020-07-20
- Primary completion
- 2021-04-20
- Completion
- 2021-04-20
- First posted
- 2020-06-30
- Last updated
- 2021-07-09
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04452006. Inclusion in this directory is not an endorsement.