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Study in Healthy Volunteers to Examine the Safety, Tolerability and Plasma Pharmacokinetics of One Intramuscular (IM) Injection of a Novel TMC278 LA Formulation at 2 Different Doses (Open Label), Followed by a Placebo-controlled Part of Multiple IM Injections at a Selected Dose (Double Blind).

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Trial Profile

Study in Healthy Volunteers to Examine the Safety, Tolerability and Plasma Pharmacokinetics of One Intramuscular (IM) Injection of a Novel TMC278 LA Formulation at 2 Different Doses (Open Label), Followed by a Placebo-controlled Part of Multiple IM Injections at a Selected Dose (Double Blind).

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 15 Sep 2021

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At a glance

  • Drugs Rilpivirine (Primary)
  • Indications HIV infections
  • Focus Pharmacokinetics
  • Sponsors Janssen R&D Ireland

Most Recent Events

  • 12 Sep 2021 Results (n=986) of population pharmacokinetics of the rilpivirine long-acting fro seven clinical studies (TMC278-C158 (NCT01031589), TMC278LAHTX1001(NCT02547870), TMC278LAHTX1002 (NCT03127189) and LAI115428(NCT01593046) LATTE-2 (NCT02120352) (NCT02951052) and(NCT02938520) published in the Journal of Antimicrobial Chemotherapy
  • 12 Dec 2011 Actual end date (Jul 2011) added as reported by ClinicalTrials.gov.
  • 12 Dec 2011 Actual initiation date changed from Feb 2010 to Jan 2010 as reported by ClinicalTrials.gov.

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