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A Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Administered VH4004280 in Healthy Participants

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Trial Profile

A Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Administered VH4004280 in Healthy Participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 31 Aug 2023

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At a glance

  • Drugs VH 4004280 (Primary)
  • Indications HIV-1 infections
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors ViiV Healthcare

Most Recent Events

  • 29 Aug 2023 Status changed from recruiting to completed.
  • 24 Feb 2023 The study protocol amended as drug-drug interaction (MAD/MAD DDI) part 3 which will investigate single dose relative bioavailability (RBA) of a new formulation of VH4004280 is added in the study. Number of treatment arms increased from 4 to 7. Planned number patients increased to 82. Primary endpoints updated for part 3 of this protocol. Maximum age of the patients 55 years will be included in this study (previously it was 50 years).
  • 24 Feb 2023 Planned number of patients changed from 80 to 82.

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