HIV-DDI
Conditions
Keywords
Single-Dose, Open-Label, Non-Blinded, Non-Placebo-, Controlled, Stratified Design
Brief summary
To investigate the pharmacokinetic drug-drug interaction potential of fixed dose antiretroviral therapies, i.e. ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved antiretroviral protease inhibitor in combination with (preferably) TRIUMEQ, on the exposure to riociguat in HIV patients on a stable dose of one of these therapies. • To Assess the safety and tolerability of riociguat treatment in combination with these fixed-dose antiretroviral therapies.
Interventions
0.5 mg, Oral (fasted conditions), 1 single dose
DRUGATRIPLA
600 mg efavirenz, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily
DRUGCOMPLERA
200 mg emtricitabine, 25 mg rilpivirine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily
DRUGSTRIBILD
150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily
DRUGTRIUMEQ
600 mg abacavir, 50 mg dolutegravir, and 300 mg lamivudine, i.e. 1 tablet, once daily
DRUGAntiretroviral protease inhibitor
Any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir ; consistent with the most recent prescribing information documents
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients aged \>=18 to \<65 years with a confirmed diagnosis of HIV receiving a stable regimen of ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir in combination with (preferably) TRIUMEQ consistent with the most recent prescribing information documents for at least 6 weeks before concomitant administration of a single oral dose of 0.5 mg riociguat * No clinical evidence of pulmonary hypertension * Written informed consent
Exclusion criteria
* Severe diseases for which it can be assumed that the pharmacokinetics or effects of the study drug will not be normal * History of coronary artery disease * Symptomatic postural hypotension (e.g. dizziness, lightheadedness) * History of bronchial asthma or any other airway disease * Renal impairment with creatinine clearance \<15 mL/min * Severe hepatic impairment (Child-Pugh class C) * Systolic blood pressure below 100 mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC of riociguat | at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose |
| Cmax of riociguat | at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose |
| AUC of riociguat main metabolite M1 (BAY 60-4552) | at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose |
| Cmax of riociguat main metabolite M1 (BAY 60-4552) | at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose |
Countries
United States
Outcome results
None listed