Safety, Tolerability, and Pharmacokinetics of Modified and Immediate Release Anatabine Citrate Formulations
- Conditions
- Pharmacokinetics of Anatabine
- Interventions
- Drug: Modified Release Formulation x (MRx)
- Registration Number
- NCT02432313
- Lead Sponsor
- Rock Creek Pharmaceuticals, Inc.
- Brief Summary
Parts 1 and 2:
Subjects take 1 dose of various formulations of the study product, and provide samples for pharmacokinetic (PK) analysis after each, with at least 7 days between doses.
Part 3:
Subjects take 2-4 doses of study product or placebo for 6 days, plus 1 additional dose, and provides samples for PK analysis.
- Detailed Description
Parts 1 and 2:
Subjects will be admitted to the clinic on the day before dosing (Day -1). Subjects will fast overnight and receive the study product in the morning of Day 1 in a non-randomized manner. Subjects will remain onsite until 24 h post-dose and will return to the clinical unit at 36 and 48 h post-dose to provide a sample for PK analysis.
There will be at least a 7-day washout between regimens. Subject will be telephoned 3-5 days after the final dose to ensure his/her ongoing well-being.
Part 3:
Subjects will be admitted to the clinic on the day before dosing (Day -1). Subjects will fast overnight (for Day 1 and Day 7) and receive the study product or placebo on a once, twice, or three times a day regimen in a randomized, double-blind manner. Subjects will remain onsite until 24 h after the final dose (Day 7), leaving the clinic on the morning of Day 8 and returning at 36 and 48 h post last-dose to provide a sample for PK analysis.
Subject will be telephoned 3-5 days after the final dose to ensure his/her ongoing well-being.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- negative for urinary cotinine
- normal test values for liver function
- provide informed consent
- clinically significant abnormal biochemistry, hematology, or urinalysis, as judged by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Modified Release Formulation x (MRx) Modified Release Formulation x (MRx) Various formulations of Modified Release anatabine citrate tablets
- Primary Outcome Measures
Name Time Method PK measures of blood anatabine 0-2 hrs (every 15 min); 2-6 hrs (every 30 min); 6-12 hr (every 60 min); at 18, 24, 36, and 48 hr
- Secondary Outcome Measures
Name Time Method reported adverse events or serious adverse events immediately post-dose to 5-days post-dose
Trial Locations
- Locations (1)
Quotient Clinical
🇬🇧Nottingham, United Kingdom