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Trial record 2 of 12 for:    anatabine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02432313
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : November 1, 2015
Sponsor:
Information provided by (Responsible Party):
Rock Creek Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE April 28, 2015
First Posted Date  ICMJE May 4, 2015
Last Update Posted Date November 1, 2015
Study Start Date  ICMJE January 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2015)
PK measures of blood anatabine [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2015)
reported adverse events or serious adverse events [ Time Frame: immediately post-dose to 5-days post-dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 28, 2015)
measures of pro-inflammatory mediators from stimulated peripheral blood mono-nuclear cells [ Time Frame: pre-dose to 12 hours post-dose ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, and Pharmacokinetics of Modified and Immediate Release Anatabine Citrate Formulations
Official Title  ICMJE 3-Part Study With 2 6-Period Single Dose Parts (Pt 1, Pt 2 Optional) Followed by a 1-Period Multiple Dose Part (Pt 3) to Evaluate Prototype Modified Release Matrix and Multi Particulate Formulations of Anatabine Citrate to Determine PK
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Pharmacokinetics of Anatabine
Intervention  ICMJE Drug: Modified Release Formulation x (MRx)
Subject receives 1 dose of a MRx and is followed. 7-day washout before dosing with another formulation
Study Arms  ICMJE Experimental: Modified Release Formulation x (MRx)
Various formulations of Modified Release anatabine citrate tablets
Intervention: Drug: Modified Release Formulation x (MRx)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2015)
37
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02432313
Other Study ID Numbers  ICMJE RCP-PK-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rock Creek Pharmaceuticals, Inc.
Study Sponsor  ICMJE Rock Creek Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sharan Sidhu, MBChB, MRCS Quotient Clinical
PRS Account Rock Creek Pharmaceuticals, Inc.
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP