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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-451840 in Healthy Subjects (Part A)

NCT02186002 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-08-09

No results posted yet for this study

Summary

The primary objective of the study was to evaluate the safety and tolerability of ACT-451840 in healthy male subjects.Secondary objectives were : to investigate the pharmacokinetics (PK) of ACT-451840; to investigate the effect of food on the PK of ACT-451840; to evaluate the urinary excretion of ACT-451840 and to investigate the antimalarial activity of ACT-451840.

Conditions

  • Healthy

Interventions

DRUG

ACT-451840 10 mg

ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water

DRUG

ACT-451840 50 mg

ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water

DRUG

ACT-451840 200 mg

ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water

DRUG

ACT-451840 500 mg

ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water

DRUG

ACT-451840 1000 mg

ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water

DRUG

ACT-451840 (Dose to be determined)

ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water

DRUG

Placebo

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Idorsia Pharmaceuticals Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • France

Study Locations

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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 NCT02186002 on ClinicalTrials.gov