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A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects

NCT04183686 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2020-08-12

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-1014-6470 in healthy subjects

Conditions

  • Healthy

Interventions

DRUG

ACT-1014-6470 (SAD)

Single dose of ACT-1014-6470; soft capsules for oral use.

DRUG

ACT-1014-6470 (MAD)

Multiple doses of ACT-1014-6470; soft capsules for oral use.

DRUG

Placebo (SAD)

Single dose of matching placebo; soft capsules for oral use.

DRUG

Placebo (MAD)

Multiple doses of matching placebo; soft capsules for oral use.

DRUG

14C-ACT-1014-6470 microtracer

Single dose of 14C-ACT-1014-6470 microtracer; soft capsules for oral use.

DRUG

14C-ACT-1014-6470 microtracer placebo

Single dose of matching placebo; soft capsules for oral use.

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
2019-11-25
Primary Completion
2020-03-15
Completion
2020-03-15

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 NCT04183686 on ClinicalTrials.gov