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A Phase 1, Randomized, Double-Blind, Single-Ascending-Dose, and Food Effect Study to Assess the Safety, Tolerability, Ventricular Repolarization, and Pharmacokinetics of S-648414 in Healthy Adult Study Participants (Part 1); A Phase 1, Randomized, Double-Blind, Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of S-648414 and A Drug-Drug Interaction Study With the CYP3A Substrate, Midazolam, in Healthy Adult Study Participants (Part 2)

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Trial Profile

A Phase 1, Randomized, Double-Blind, Single-Ascending-Dose, and Food Effect Study to Assess the Safety, Tolerability, Ventricular Repolarization, and Pharmacokinetics of S-648414 in Healthy Adult Study Participants (Part 1); A Phase 1, Randomized, Double-Blind, Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of S-648414 and A Drug-Drug Interaction Study With the CYP3A Substrate, Midazolam, in Healthy Adult Study Participants (Part 2)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 25 Oct 2021

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At a glance

  • Drugs S 648414 (Primary) ; Dolutegravir; Midazolam
  • Indications HIV infections
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Shionogi

Most Recent Events

  • 28 Oct 2020 Status changed from recruiting to completed.
  • 20 Oct 2020 Planned End Date changed from 1 Oct 2020 to 1 Nov 2020.
  • 20 Oct 2020 Planned primary completion date changed from 1 Oct 2020 to 1 Nov 2020.

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