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

Study Overview
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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.

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

Conditions
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Healthy Adult Subjects

Intervention / Treatment
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* Drug: Methylnaltrexone bromide


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Methylnaltrexone bromide | Drug: Methylnaltrexone bromide<br>* Subcutaneous MNTX<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |