Interaction With HIV Antiretroviral Agents

NCT02556268 | Completed Phase 1 FDA Drug

• 1 other identifier: 17957
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV-DDI

Keywords

Single-Dose, Open-Label, Non-Blinded, Non-Placebo-; Controlled, Stratified Design

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (5)

Riociguat and ATRIPLA

EXPERIMENTAL

Drug: Riociguat (Adempas, BAY 63-2521); Drug: ATRIPLA

Riociguat and COMPLERA

EXPERIMENTAL

Drug: Riociguat (Adempas, BAY 63-2521); Drug: COMPLERA

Riociguat and STRIBILD

EXPERIMENTAL

Drug: Riociguat (Adempas, BAY 63-2521); Drug: STRIBILD

Riociguat and TRIUMEQ

EXPERIMENTAL

Drug: Riociguat (Adempas, BAY 63-2521); Drug: TRIUMEQ

Riociguat and antiretroviral protease inhibitor with TRIUMEQ

EXPERIMENTAL

Drug: Riociguat (Adempas, BAY 63-2521); Drug: Antiretroviral protease inhibitor

Interventions

Riociguat (Adempas, BAY 63-2521) DRUG

0.5 mg, Oral (fasted conditions), 1 single dose

Riociguat and ATRIPLA; Riociguat and COMPLERA; Riociguat and STRIBILD; Riociguat and TRIUMEQ; Riociguat and antiretroviral protease inhibitor with TRIUMEQ

ATRIPLA DRUG

600 mg efavirenz, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily

Riociguat and ATRIPLA

COMPLERA DRUG

200 mg emtricitabine, 25 mg rilpivirine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily

Riociguat and COMPLERA

STRIBILD DRUG

150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily

Riociguat and STRIBILD

TRIUMEQ DRUG

600 mg abacavir, 50 mg dolutegravir, and 300 mg lamivudine, i.e. 1 tablet, once daily

Riociguat and TRIUMEQ

Antiretroviral protease inhibitor DRUG

Any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir ; consistent with the most recent prescribing information documents

Riociguat and antiretroviral protease inhibitor with TRIUMEQ

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Unknown Facility

Orlando, Florida, 32803, United States

Location

Unknown Facility

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Interventions

riociguat; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine, Rilpivirine, Tenofovir Drug Combination; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; abacavir, dolutegravir, and lamivudine drug combination

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Rilpivirine; Nitriles; Cobicistat; Carbamates; Acids, Acyclic; Carboxylic Acids; Thiazoles; Sulfur Compounds; Azoles; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 22, 2015
• Study Start: February 23, 2016
• Primary Completion: December 7, 2016
• Study Completion: December 7, 2016
• Last Updated: December 6, 2017

Record last verified: 2017-12

Locations

US (2)