A Phase 1 interventional study of metyrapone & oxazepam and metyrapone & oxazepam in Cocaine Use Disorder and Tobacco Use Disorder, sponsored by Embera NeuroTherapeutics, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-22.
Sponsored by Embera NeuroTherapeutics, Inc. · Phase 1, Interventional, and Treatment
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.
This study is a Phase 1, double blind, single and multiple rising dose tolerance study of EMB-001 (metyrapone/oxazepam combination) in otherwise healthy adults who have tobacco use disorder. There will be 3 cohorts, each with 8 subjects (6 active: 2 placebo), for a total of 24 subjects. During the treatment period, subjects will receive a single dose of EMB 001 on Day 1, followed 24 hours later by the start of multiple doses twice daily for 7 days, and then a final morning dose on the last dosing day (Day 9). This design allows for characterization of EMB-001 single dose PK for 24 hours, followed by assessment of repeat dose PK in the multiple-dose phase. 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. Later studies may also assess the efficacy of this drug combination in treating cocaine use disorder, tobacco use disorder, and/or other disorders.
Exclusion Criteria:
Subjects will receive capsules containing no active pharmaceutical ingredients.
Drug: Placebo
270 mg metyrapone and 12 mg oxazepam, given once for the single-dose phase of the study, followed by BID dosing for approximately one week
Drug: metyrapone & oxazepam
540 mg metyrapone and 24 mg oxazepam, given once for the single-dose phase of the study, followed by BID dosing for approximately one week
Drug: metyrapone & oxazepam
720 mg metyrapone and 24 mg oxazepam, given once for the single-dose phase of the study, followed by BID dosing for approximately one week
Drug: metyrapone & oxazepam
6 subjects will receive active study drug (a low dose combination of metyrapone \& oxazepam) and 2 subjects will receive placebo.
Also known as: Cohort 1
6 subjects will receive active study drug (a medium dose combination of metyrapone \& oxazepam) and 2 subjects will receive placebo.
Also known as: Cohort 2
6 subjects will receive active study drug (a high dose combination of metyrapone \& oxazepam) and 2 subjects will receive placebo.
Also known as: Cohort 3
Each cohort will have 2 subjects receiving placebo
Also known as: All Cohorts
Safety/Tolerability based on multiple safety parameters (adverse events (AE), physical examinations, vital signs, 12-lead ECG, Sheehan Suicidality Tracking Scale (S STS) and laboratory tests)
Safety will be assessed through monitoring of adverse events (AE), physical examinations, vital signs, 12-lead ECG, Sheehan Suicidality Tracking Scale (S STS) and laboratory tests.
Time frame: Daily on Days 1-12, and on Day 17. Study Completion occurs on Day 17.
Pharmacokinetics (Plasma PK parameters will be serially assessed for oxazepam, metyrapone, and for the primary metabolite of metyrapone, metyrapol)
Plasma PK parameters will be serially assessed for oxazepam, metyrapone, and for the primary metabolite of metyrapone, metyrapol.
Time frame: After single- and multiple-dosing- Samples will be drawn on Day 1 and Day 10 at the following times Pre-dose, .25, .5, .75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, & 48 hours.
Craving/addiction measures
Exploratory efficacy endpoints will include the following craving and addiction measures: 1. The Smoking Urges Questionnaire-Brief 2. Minnesota Nicotine Withdrawal Scale 3. Number of cigarettes smoked, breath carbon monoxide, and urine cotinine.
Time frame: These will be assessed at baseline and on Study Day 9
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Embera NeuroTherapeutics, Inc.