WHO ICTRP trial

A Phase I, open-label trial to investigate pharmacokinetics, safety and…

EUCTR2006-002183-26-GB · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2006-002183-26-GB
Public title A Phase I, open-label trial to investigate pharmacokinetics, safety and tolerability of TMC125 at steady-state in treatment-experienced HIV-1 infected children.
Scientific title A Phase I, open-label trial to investigate pharmacokinetics, safety and tolerability of TMC125 at steady-state in treatment-experienced HIV-1 infected children.
Primary sponsor Tibotec Pharmaceuticals Ltd
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Germany;United Kingdom
Conditions HIV-1 MedDRA version: 8.1 Level: LLT Classification code 10020192 Term: HIV-1
Interventions Product Name: TMC125 Product Code: TMC125 (formulation - F060) Pharmaceutical Form: Tablet CAS Number: 269055-15-4 Current Sponsor code: TMC125 Other descriptive name: R165335, Lab code 094268 Concentration unit: mg milligram(s)…
Registration date Jul 22, 2006
Target size 40
Secondary IDs TMC125-C126;2006-002183-26-DE
Registry page clinicaltrialsregister.eu

At a glance

  • Yes Results available

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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