Study of Interactions Between GBR 12909 and Cocaine
This is a human laboratory clinical pharmacology study that will assess potential interactions between intravenous (i.v.) cocaine and three escalating oral doses (50, 70 and 100 mg) of GBR 12909, which is 1-[2-[bis(4-fluorophenyl)methoxy]ethyl]-4-(3-phenylpropyl) piperazine dihydrochloride.
May 23, 2017
The primary objective of this study is to determine safety of GBR 12909 administration and if there are significant interactions between GBR 12909 treatment concurrent with i.v. cocaine infusions of 20 and 40 mg by measuring adverse events and cardiovascular responses [heart rate (HR), blood pressure (BP), and electrocardiogram (ECG)]. Note: A significant interaction is defined as: more than 50% of the subjects treated with GBR 12909 experience a pharmacodynamic interaction when challenged with cocaine, which brings the stopping criteria (section 12.4.5) into effect.
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