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A Single-center, Randomized, Placebo-Controlled Phase I Study Designed to Assess the Safety, Tolerability, Pharmacokinetics, ECG Effects, Food Effect, and Drug-drug Interaction (DDI) of Hormonal Contraceptives of PTI-428 in Healthy Female Volunteers

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A Single-center, Randomized, Placebo-Controlled Phase I Study Designed to Assess the Safety, Tolerability, Pharmacokinetics, ECG Effects, Food Effect, and Drug-drug Interaction (DDI) of Hormonal Contraceptives of PTI-428 in Healthy Female Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Nesolicaftor (Primary) ; Ethinylestradiol/levonorgestrel
  • Indications Cystic fibrosis
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Proteostasis Therapeutics

Most Recent Events

  • 22 May 2018 Status changed from recruiting to completed.
  • 22 Sep 2016 According to a Proteostasis Therapeutics media release, data from his study will be presented at the 30th Annual North American Cystic Fibrosis Conference (NACFC).
  • 29 Jul 2016 New trial record

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