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

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01366326
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 1
• Patients Per Site Per Month: 19.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Adult Subjects	Drug: Methylnaltrexone bromide	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multiple-Dose, Open-Label Study to Evaluate the Pharmacokinetics of MNTX in Healthy Adult Subjects
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Methylnaltrexone bromide	Drug: Methylnaltrexone bromide; Subcutaneous MNTX

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Progenics Pharmaceuticals, Inc.	Tarrytown	New York	United States	10591

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

• Study Director: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT01366326
• Other Study ID Numbers: MNTX 1109
• First Posted: Jun 6, 2011
• Last Update Posted: Nov 29, 2019
• Last Verified: Nov 1, 2019

• Additional relevant MeSH terms: Bromides; Methylnaltrexone

Study Results

No Results Posted as of Nov 29, 2019