Dolutegravir Paediatric Liquid Formulation Study (QSC200728)
Research type
Research Study
Full title
Non-randomized, sequential, fixed-sequence evaluation of prototype dolutegravir liquid formulations versus 5mg dolutegravir dispersible tablets following single-dose fasted-state administrations to normal healthy adult participants
IRAS ID
256861
Contact name
Riya Moodley
Contact email
Sponsor organisation
Viiv Healthcare UK Limited
Eudract number
2018-003613-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 11 days
Research summary
Dolutegravir, or DTG, (the test medicine) is being developed by ViiV Healthcare UK Limited as a liquid medicine to swallow to treat babies that are infected with Human Immunodeficiency Virus (HIV). It is not yet approved by the Medicines & Healthcare Products Regulatory Agency (MHRA) or the United States (US) Food and Drug Administration; however, other formulations (recipes) of the test medicine have been approved and are currently used by adult patients.
HIV is a virus that damages the cells in the immune system and weakens a person’s ability to fight everyday infections and diseases. Currently HIV cannot be cured and not all people respond fully to existing treatments. When not treated adequately, the immune system can get damaged leading to AIDS (acquired immune deficiency syndrome). AIDS is the name used to describe the most severe phase of HIV where a patient’s immune system is so weak that they get an increasing number of potentially life-threatening infections and illnesses.
The test medicine controls the HIV virus and may give additional treatment options for babies with HIV in the future.
The purpose of this study is to compare the blood levels of the test medicine when given as three different formulations (recipes). One formulation has already been used in studies with people, the others are new formulations that are more suitable for future use in children. We will also look at the safety and tolerability of the test formulations.
The study will consist of 3 periods involving up to 18 healthy adult male and female volunteers. Periods 1, 2 and 3 will evaluate a single reference dose (2 x 5mg dispersible DTG tablet dispersed in water) and 2 liquid prototype DTG formulations (containing a target total dose of 10mg DTG).
REC name
Wales REC 2
REC reference
19/WA/0112
Date of REC Opinion
11 Apr 2019
REC opinion
Favourable Opinion