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Effects of Rifampin on the Pharmacokinetics of Ataluren

NCT02409004 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-12-22

No results posted yet for this study

Summary

This will be a single centre, Phase I, open-label, one cohort, one dose level, fixed-sequence, drug interaction study in healthy volunteers. The objective of this study is to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Ataluren

Powder for oral suspension (supplied in sachets) 1X 125 mg + 1 x 250 mg + 1000 mg (total of 1375 mg)

DRUG

Rifampin

Capsule 2x3oo mg Oral

Sponsors & Collaborators

Principal Investigators

  • Oscar Laskin, MD · PTC Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02409004 on ClinicalTrials.gov