Safety, Tolerability, and Pharmacokinetics of Modified and Immediate Release Anatabine Citrate Formulations

Rock Creek Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics of Anatabine

Treatments: Drug: Modified Release Formulation x (MRx)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02432313

RCP-PK-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

37 participants in 1 patient group

Modified Release Formulation x (MRx)

Experimental group

Description:

Various formulations of Modified Release anatabine citrate tablets

Treatment:

Drug: Modified Release Formulation x (MRx)