Healthy Adults
Conditions
Brief summary
This double-blind, randomized, two-cohort, placebo-controlled, parallel group study characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses and at steady-state during multiple dosing and assessed the effects of aging on the pharmacokinetics, safety and tolerability of MNTX.
Interventions
DRUGmethylnaltrexone
DRUGplacebo
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Males and females who were between the ages of 18 and 45 years and healthy males and females who were 65 years of age and older. 2. Subjects who were non-smokers 3. Subjects with body weights within range of 70-100 kg (154-220 lbs).
Exclusion criteria
1. Subjects who had previously been exposed to MNTX 2. Subjects with a history of vasovagal episodes or fainting within the past five years 3. Subjects with a history of psychiatric or neurologic disorder 4. Subjects with a history of narrow-angle glaucoma or intraocular hypertension 5. Subjects who had tested positive for hepatitis B surface antigen, IgM hepatitis B core antibody, hepatitis C antibody, or HIV 6. Subjects who have had a diagnosis of alcohol or substance dependence.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance of MNTX | 7 days | Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects with Adverse Events | 7 days | Safety and tolerability of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses |
| Half-life of MNTX | 7 days | Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses |
| Volume of distribution of MNTX | 7 days | Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses |
| Area under the plasma concentration (AUC) of MNTX | 7 days | Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses |
Countries
United States
Outcome results
None listed