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NCT02409004
A Phase I Study Assessing the Effects of Rifampin on the Pharmacokinetics of Ataluren in Healthy Subjects
Phase 1 trial testing Ataluren in Healthy in 15 participants. Completed in 1 March 2015.
1 March 2015
Quick facts
| Lead sponsor | PTC Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 1 February 2015 |
| Primary completion | 1 March 2015 |
| Estimated completion | 1 March 2015 |
| Sites | 1 location across Canada |
Drugs / interventions tested
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
PTC Therapeutics — full company profile →
Who can join
Adults 18 to 55, male only, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Area under the plasma concentration versus time curve (AUC)
Time frame: 12 days
The objective of this study is to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting conditions. -
Maximum plasma concentration (Cmax)
Time frame: 12 days
The objective of this study is to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting conditions.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02409004
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ataluren
Trials testing the same drug.
- NCT04336826 — A Study to Evaluate the Safety and Pharmacokinetics of Ataluren in Participants From ≥6 Months to <2 Years of Age With N · Phase 2 · completed
- NCT03796637 — A Study to Assess Dystrophin Levels in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD) Who Have · Phase 2 · completed
- NCT04117880 — A Phase 2 Open Label Extension Study in Participants With Nonsense Mutation Aniridia · Phase 2 · withdrawn
- NCT03648827 — A Study to Assess Dystrophin Levels in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD) · Phase 2 · completed
- NCT03179631 — Long-Term Outcomes of Ataluren in Duchenne Muscular Dystrophy · Phase 3 · completed
Other recruiting trials for Healthy
Currently open trials in the same condition.
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- NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
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- NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
- NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting
Other PTC Therapeutics trials
Trials by the same sponsor.
- NCT06302348 — A Study of Sepiapterin in Participants With Phenylketonuria (PKU) · Phase 3 · recruiting
- NCT05515536 — A Study to Assess the Safety and Efficacy of Vatiquinone in Participants With Friedreich Ataxia · Phase 3 · active not recruiting
- NCT05485987 — A Study of Vatiquinone for the Treatment of Participants With Friedreich Ataxia · Phase 2 · completed
- NCT05218655 — A Safety Study for Previously Treated Vatiquinone (PTC743) Participants With Inherited Mitochondrial Disease · Phase 3 · completed
- NCT05358717 — A Study to Evaluate the Safety and Efficacy of PTC518 in Participants With Huntington's Disease (HD) · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02409004 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PTC Therapeutics
- Last refreshed: 20 December 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02409004.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing