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

NCT02432313 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2015-11-02

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics of Anatabine

Interventions

DRUG

Modified Release Formulation x (MRx)

Subject receives 1 dose of a MRx and is followed. 7-day washout before dosing with another formulation

Sponsors & Collaborators

  • Rock Creek Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Sharan Sidhu, MBChB, MRCS · Quotient Clinical

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02432313 on ClinicalTrials.gov