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Study to Evaluate Safety and Tolerability of ACT-709478 in Healthy Subjects

NCT03165097 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2019-12-24

No results posted yet for this study

Summary

The primary purpose of this study is to evaluate the safety and tolerability of ascending multiple doses of ACT-709478 in healthy male and female subjects

Conditions

  • Healthy Subjects

Interventions

DRUG

ACT-709478

Hard gelatine capsules for oral administration

DRUG

Placebo

Placebo capsules matching ACT-709478 capsules

DRUG

Midazolam

Midazolam oral solution (2 mg/mL) applied with a syringe

DRUG

ACT-709478 combined with midazolam

Hard gelatine capsules for oral administration (ACT-709478) to be taken first followed by Midazolam oral solution (2 mg/mL) applied with a syringe

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Study Director · Idorsia Pharmaceuticals Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-07-07
Primary Completion
2018-11-15
Completion
2018-12-28

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT03165097 on ClinicalTrials.gov