NCT04798209 - A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-777991 in Healthy Subjects | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 29, 2021

Primary Completion Date

January 26, 2022

Study Completion Date

May 21, 2022

Conditions

Healthy

Interventions

DRUG

ACT-777991 (SAD)

ACT-777991 administered as hard capsules for oral use.

DRUG

ACT-777991 (MAD)

ACT-777991 administered as hard capsules for oral use, once daily.

DRUG

Placebo (SAD)

ACT-777991 matching placebo administered as hard capsules for oral use.

DRUG

Placebo (MAD)

Matching placebo administered as hard capsules for oral use, once daily.

DRUG

14C-ACT-777991 microtracer (SAD - Absolute Bioavailability)

Single dose of 14C-ACT-777991 microtracer, administered intravenously.

DRUG

Microtracer matching placebo (SAD - Absolute Bioavailability)

Single dose of 14C-ACT-777991 microtracer matching placebo, administered intravenously.

DRUG

14C-ACT-777991 microtracer (MAD - ADME)

Single dose of 14C-ACT-777991 microtracer, oral solution..

DRUG

Microtracer matching placebo (MAD - ADME)

Single dose of 14C-ACT-777991 microtracer matching placebo, oral solution.

Trial Locations (1)

QPS Netherlands B.V., Groningen