check_circleStudy Completed

HIV-DDI

Bayer Identifier:

17957

ClinicalTrials.gov Identifier:

NCT02556268

EudraCT Number:

Not Available

EU CT Number:

Not Available
Interaction with HIV antiretroviral agents

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • -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

  • - 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

Trial summary

Enrollment Goal
40
Trial Dates
February 2016 - December 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Boston, 02118, United States
Completed
Orlando, 32803, United States

Primary Outcome

  • AUC of riociguat
    date_rangeTime Frame:
    at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax of riociguat
    date_rangeTime Frame:
    at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC of riociguat main metabolite M1 (BAY 60-4552)
    date_rangeTime Frame:
    at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax of riociguat main metabolite M1 (BAY 60-4552)
    date_rangeTime Frame:
    at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
    enhanced_encryption
    Safety Issue:
    No

Trial design

Potential pharmacokinetic interaction of human immunodeficiency virus (HIV) antiretroviral agents as fixed-dose combinations and riociguat in HIV patients
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
5

Additional Information

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