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

NCT04798209 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-06-21

No results posted yet for this study

Summary

A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-777991 in healthy subjects.

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.

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Idorsia Pharmaceuticals Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-29
Primary Completion
2022-01-26
Completion
2022-05-21

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04798209 on ClinicalTrials.gov