Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Rilpivirine in Healthy Subjects
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Treatment of human immunodeficiency virus (HIV) infection requires daily oral administration
      of a combination of antiretroviral drugs to reduce the patient's HIV levels. Dolutegravir
      (DTG), a HIV-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1
      reverse transcriptase inhibitor (NNRTI), are approved for the treatment of HIV infection.
      This study is aimed to evaluate the relative bioavailability and food effect of single doses
      of several experimental fixed dose combination (FDC) tablets of Dolutegravir 50 milligrams
      (mg) and Rilpivirine 25 mg (DTG/RPV 50 mg/25 mg) relative to co-administration of a single
      dose of the reference single entity products (DTG 50 mg and RPV 25 mg) in healthy adult
      subjects. This is a 2-part study. Part 1 will be conducted as a randomized, open label,
      3-way, crossover design in 24 subjects. Part 1 will evaluate the relative bioavailability of
      up to 4 test formulations relative to the reference single entity products administered in
      fed state. Part 2 will be conducted as a randomized, open-label, 3-way crossover design in 3
      distinct cohorts each with 12 subjects. Part 2 will evaluate the relative bioavailability of
      up to 3 most promising FDC formulation selected from Part 1 (DTG/RPV FDC-1, DTG/RPV FDC-2,
      DTG/RPV FDC-3) administered in fasted and fed state. Subjects will also receive the reference
      treatment from Part 1 co-administered under fasted conditions. This study will consist of a
      screening visit, three treatment periods each with a single dose of study drug separated by a
      washout of at least 9 days and a follow-up visit. The total duration of participation of a
      subject in this study will be approximately 10 weeks.
    


Intervention name(s): DTG 50 mg; RPV 25 mg; DTG/RPV 50 mg/25 mg: Product Code AS; DTG/RPV 50 mg/25 mg: Product Code AM; DTG/RPV 50 mg/25 mg: Product Code AQ; DTG/RPV 50 mg/25 mg: Product Code AK; DTG/RPV 50 mg/25 mg: Product Code AR
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dolutegravir will be supplied as a white, film-coated, round tablet with a unit dose strength of 50 mg to be administered orally; Rilpivirine will be supplied as a white to off-white, film-coated, round biconvex tablet with a unit dose strength of 25 mg to be administered orally; DTG/RPV will be supplied as a pink, film coated, round biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally; DTG/RPV will be supplied as a pink, film coated, oval, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally; DTG/RPV will be supplied as a pink, film coated, round, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally; DTG/RPV will be supplied as pink, film coated, oval, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally; DTG/RPV will be supplied as a pink, film coated, round, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dolutegravir; safety; Rilpivirine; fixed dose combination; relative bioavailability