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
Price :
$35
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At a glance
- Drugs Rilpivirine (Primary)
- Indications HIV infections
- Focus Pharmacokinetics
- Sponsors Janssen R&D Ireland
- 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.