Acute Dosing of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-003)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01934647
• Date of registration: 30/08/2013
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: Acute Dosing of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-003)
• Scientific title: A Non-randomized, Single-Panel, Open-Label Trial to Study the Safety, Tolerability and Pharmacodynamics of MK-8892 Acute Dosing in Subjects With Moderate to Severe Pulmonary Arterial Hypertension
• Date of first enrolment: November 22, 2013
• Target sample size: 7
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01934647
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion criteria

Inclusion Criteria:

- postmenopausal female or if female of reproductive potential, remains abstinent or
uses two acceptable methods of birth control during 14 days after dosing with MK-8892

- has suspected PAH classified in one of the following sub-groups: idiopathic,
heritable, drug- or toxin-induced, or associated with connective tissue disease, as
defined by the Dana Point 2008 Clinical Classification

- has a clinical indication for right heart catheterization

- PAH classified as World Health Organization (WHO) functional class II or III

Exclusion Criteria:

- has a medical history indicating a secondary cause of Pulmonary Hypertension (PH) or a
non-included etiology of PAH including the following tests within 6 months of Visit 1:
Echo indicating significant left heart disease, valvular disease, or structural
defects; function test indicating significant pulmonary disease; imaging test
indicating veno-occlusive disease; perfusion scan indicating thromboembolic disease;
abdominal ultrasound indicating cirrhosis; positive test for human immunodeficiency
virus (HIV)

- has persistent or permanent atrial fibrillation, significantly impaired gas exchange,
history of radiation of the lung or mediastinum, hepatic or hepatobiliary disease,
immunodeficiencies or latent bleeding risk

- has estimated Glomerular Filtration Rate (GFR) <45 mL/min

- has alanine aminotransferase test (ALT) serum glutamic pyruvic transaminase (SGPT) or
aspartate aminotransferase test (AST) serum glutamic oxaloacetic transaminase (SGOT)
>= 3 x upper limit of normal (ULN) at Visit 1

- has a systolic blood pressure (BP) <105 mmHg, or heart rate (HR) > 100 beats/min at
Visit 1 (Day -7 to -1)

- has previously received specific therapy for PAH within 4 weeks prior to Visit 1

- has taken sildenafil, valdenafil or a nitrate within 24 hours prior to Visit 2 date

- has taken tadalafil within 7 days prior to Visit 2 date

- has taken 2 or more specific PAH medications concomitantly within 4 weeks of
anticipated Visit 2 date. Only treatment naïve subjects or subjects on stable
PAH-specific monotherapy with an endothelin receptor antagonist ([ERA]; bosentan,
ambrisentan, or macitentan) or a prostacyclin analog ([PCA]; treprostinil,
epoprostenol, or iloprost) are eligible. PAH monotherapy with one of these medications
may continue without interruption during this study

- has taken a soluble guanylate cyclase (sGC) activator (riociguat) within 24 hours of
anticipated Visit 2 date.

- has taken diltiazem immediate release within 1 day or diltiazem extended release
within 2 days prior to Visit 2 date

- is currently taking potent inhibitors or inducers of Cytochrome P450 3A4 (CYPA4), or
is consuming >1 liter of grapefruit juice per day

- is pregnant or breastfeeding or expecting to conceive during study or post study
follow-up period

- has donated 500 mL of blood within prior 60 days

- is currently participating in or has within the prior three months participated in a
study with an investigational compound or device



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: MK-8892

Primary Outcome(s)

Peak Percent Change From Baseline in Pulmonary Vascular Resistance (PVR) at the Highest Acutely Tolerated (HAT) Dose of MK-8892 [Time Frame: Baseline and up to 5 hours post-dose]

Secondary ID(s)

MK-8892-003

8892-003

2013-001680-23

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01934647