Pharmacokinetics of Anatabine
Conditions
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.
Interventions
DRUGModified Release Formulation x (MRx)
Subject receives 1 dose of a MRx and is followed. 7-day washout before dosing with another formulation
Sponsors
Rock Creek Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* negative for urinary cotinine * normal test values for liver function * provide informed consent
Exclusion criteria
* clinically significant abnormal biochemistry, hematology, or urinalysis, as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| reported adverse events or serious adverse events | immediately post-dose to 5-days post-dose |
Other
| Measure | Time frame |
|---|---|
| measures of pro-inflammatory mediators from stimulated peripheral blood mono-nuclear cells | pre-dose to 12 hours post-dose |
Countries
United Kingdom
Outcome results
None listed