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A Phase 1, Open-label Study in Healthy Female Subjects to Investigate the Effect of JNJ-56136379 at Steady-state on the Single-dose Pharmacokinetics of Ethinylestradiol and Drospirenone (Oral Contraceptive) and on the Single-dose Pharmacokinetics of Midazolam (Probe Substrate for Cytochrome P450 3A4)

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Trial Profile

A Phase 1, Open-label Study in Healthy Female Subjects to Investigate the Effect of JNJ-56136379 at Steady-state on the Single-dose Pharmacokinetics of Ethinylestradiol and Drospirenone (Oral Contraceptive) and on the Single-dose Pharmacokinetics of Midazolam (Probe Substrate for Cytochrome P450 3A4)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 13 Dec 2022

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At a glance

  • Drugs Bersacapavir (Primary) ; Drospirenone/ethinylestradiol; Midazolam
  • Indications Hepatitis B
  • Focus Pharmacokinetics
  • Sponsors Janssen Sciences Ireland UC

    • Most Recent Events

    • 01 Dec 2022 Results of pooled analysis from NCT03945539, NCT03111511 assessing Drug-Drug Interactions With the Hepatitis B Virus Capsid Assembly Modulator JNJ-56136379 published in the Clinical Pharmacology in Drug Development
    • 01 Sep 2017 Status changed from recruiting to completed.
    • 18 Apr 2017 New trial record

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