NCT04452006 - 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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 20, 2020

Primary Completion Date

April 20, 2021

Study Completion Date

April 20, 2021

Conditions

Healthy

Interventions

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.

Trial Locations (1)

14050

Parexel International GmbH, Berlin