Single and Multiple Rising Dose Study of Safety and PK of Metyrapone/Oxazepam Combination (EMB-001)
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam)
in otherwise healthy adults who are regular cigarette smokers. There will be 3 groups of 8
subjects; in each group, 6 subjects will get the drug combination and 2 will get placebo.
Neither the subjects nor the study personnel will know who got drug and who got placebo
(double-blind). In the first group the drug doses will be low, and they will be increased in
the second and third groups. Subjects will receive a single dose on Day 1, followed 24 hours
later by the start of doses twice daily for 7 days, and then a final morning dose on the last
day. The levels of the drugs in the blood will be assessed by repeated blood draws after the
first day and after the end of dosing. Safety will be assessed after the single dose and
repeated dosing. Effects of study drug on smoking and craving cigarettes will be assessed at
the end of repeated dosing. The hypothesis is that this drug combination will be safe, with
relatively few side effects.