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Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-462206

NCT01954589 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-07-10

No results posted yet for this study

Summary

A study of ACT-462206 to evaluate the tolerability, safety, pharmacokinetics, and pharmacodynamic of ascending single doses of ACT-462206, a novel dual orexin receptor antagonist in healthy male subjects.

Conditions

  • Safety
  • Tolerability
  • Pharmacodynamics
  • Pharmacokinetics

Interventions

DRUG

ACT-462206 5 mg

DRUG

ACT-462206 25 mg

DRUG

ACT-462206 100mg

DRUG

ACT-462206 200mg

DRUG

ACT-462206 400mg

DRUG

ACT-462206 1000 mg

DRUG

ACT-462206 1500mg

DRUG

Almorexant 400mg

DRUG

Placebo

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Petra Baecker, MD · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Netherlands

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 NCT01954589 on ClinicalTrials.gov