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

Healthy Adult Subjects Clinical Trial

Official title:

A Multiple-Dose, Open-Label Study to Evaluate the Pharmacokinetics of MNTX in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366326
• Other study ID #: MNTX 1109
• Status: Completed
• Phase: Phase 1
• Start date: July 2010
• Est. completion date: August 2010

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

Drug:
• Methylnaltrexone bromide
Subcutaneous MNTX

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals, Inc.	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days
Secondary	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.	7 Days
Secondary	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.	7 Days