This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
37
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, United States
Peak Plasma Concentration (Cmax) of oral doses of MNTX
To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers
Time frame: 7 days
Peak Time of Maximum Concentration (Tmax) of oral doses of MNTX
To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers
Time frame: 7 days
Area Under the Plasma Concentration versus Time Curve (AUC) of oral doses of MNTX
To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers
Time frame: 7 days
Half-life of oral doses of MNTX
To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers
Time frame: 7 days
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