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Trial record 2 of 10 for:    anatabine

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

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ClinicalTrials.gov Identifier: NCT02432313
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : November 2, 2015
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Pharmacokinetics of Anatabine Drug: Modified Release Formulation x (MRx) Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : January 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Modified Release Formulation x (MRx)
Various formulations of Modified Release anatabine citrate tablets
Drug: Modified Release Formulation x (MRx)
Subject receives 1 dose of a MRx and is followed. 7-day washout before dosing with another formulation




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. reported adverse events or serious adverse events [ Time Frame: immediately post-dose to 5-days post-dose ]

Other Outcome Measures:
  1. measures of pro-inflammatory mediators from stimulated peripheral blood mono-nuclear cells [ Time Frame: pre-dose to 12 hours post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432313


Locations
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United Kingdom
Quotient Clinical
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Rock Creek Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Sharan Sidhu, MBChB, MRCS Quotient Clinical

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Responsible Party: Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02432313     History of Changes
Other Study ID Numbers: RCP-PK-002
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: November 2, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
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Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action