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

Phase 1

Completed

• Conditions: Healthy Adult Subjects
• Interventions: Drug: Methylnaltrexone bromide

• Registration Number: NCT01366326
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-06
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Methylnaltrexone bromide	Methylnaltrexone bromide

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax) of MNTX and its Metabolites	7 days	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.

Secondary Outcome Measures

Name	Time	Method
Peak Time of Maximum Concentration (Tmax) of MNTX and its Metabolites	7 Days	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.
Area Under the Plasma Concentration versus Time Curve (AUC) of MNTX and its Metabolites.	7 Days	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.

Trial Locations

Locations (1)

Progenics Pharmaceuticals, Inc.; 🇺🇸 Tarrytown, New York, United States