Evaluate the Pharmacokinetics (PK) of Methylnaltrexone (MNTX) in Healthy Adult Subjects

Bausch Health Americas, Inc.20 enrolled

Overview

MNTX 1109 is a single center, open label study, composed of normal healthy adult subjects to evaluate the PK of MNTX and its metabolites administered once daily as a subcutaneous (SC) injection for a period of seven days. Blood samples will be obtained at screening and for drug concentration data.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Adult Subjects

Interventions

Methylnaltrexone bromideDRUG

Subcutaneous MNTX

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Body weight ≥40 kg (88 lb) 2. In good health with no clinically significant abnormal findings on the physical examination, medical history or the screening 12-lead ECG 3. Non-smoker 4. Has no known allergies to study drug or other related chemically-related compounds (i.e. naltrexone, naloxone). Exclusion Criteria: 1. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease 2. History of clinically significant allergies 3. Positive urine screen for drugs 4. History of positive blood screen for human immunodeficiency virus (HIV), hepatitis B virus (Hep B), or hepatitis C virus (HCV) 5. Prior exposure, allergy or known hypersensitivity to methylnaltrexone 6. Diagnosis of alcohol or substance dependence within the past 12 months.

Locations (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, United States

Outcomes

Primary Outcomes

Peak Plasma Concentration (Cmax) of MNTX and its Metabolites

To evaluate the PK profile of MNTX and its metabolites when administered as a SC injection once daily for seven days in healthy adult subjects.

Time frame: 7 days

Secondary Outcomes

Peak Time of Maximum Concentration (Tmax) of MNTX and its Metabolites

To evaluate the PK profile of MNTX and its metabolites when administered as a SC injection once daily for seven days in healthy adult subjects.

Time frame: 7 Days

Area Under the Plasma Concentration versus Time Curve (AUC) of MNTX and its Metabolites.

To evaluate the PK profile of MNTX and its metabolites when administered as a SC injection once daily for seven days in healthy adult subjects.

Time frame: 7 Days

Data from ClinicalTrials.gov

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