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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Adult Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Methylnaltrexone bromide

Group Type EXPERIMENTAL

Methylnaltrexone bromide

Intervention Type DRUG

Subcutaneous MNTX

Interventions

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Methylnaltrexone bromide

Subcutaneous MNTX

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes