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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

NCT04452006 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-07-09

No results posted yet for this study

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

  • 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.

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Idorsia Pharmaceuticals Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-07-20
Primary Completion
2021-04-20
Completion
2021-04-20

Countries

  • Germany

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 NCT04452006 on ClinicalTrials.gov