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Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-389949 in Healthy Subjects

NCT02099201 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2018-07-10

No results posted yet for this study

Summary

This is a single-center, double-blind, parallel-group, randomized, placebo-controlled, multiple-ascending oral dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ACT-389949 in healthy subjects.

Part A of the study will evaluate the safety and tolerability following once a day oral dosing of ACT-389949 for 9 days and investigate ACT-389949 pharmacokinetics and pharmacodynamics.

Part B of the study will evaluate the safety and tolerability of ACT-389949 following a maximum of two different oral dosing regimens: ACT-389949 given either every 3 days for 13 days or every 2 days for 9 days (5 doses for each regimen).

Part C of the study, if required, will provide additional information to that obtained from Parts A and B in terms of safety, tolerability, pharmacokinetics, and pharmacodynamics of ACT-389949.

Conditions

  • Healthy Subjects

Interventions

DRUG

ACT-389949 40 mg

DRUG

ACT-389949 200 mg

Predicted dose

DRUG

ACT-389949 800 mg

Predicted dose

DRUG

ACT-389949 (Group C1 dose to be selected)

DRUG

ACT-389949 (Group C2 dose to be selected)

DRUG

Placebo

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Alison Mackie, MSc · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United Kingdom

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 NCT02099201 on ClinicalTrials.gov