Trial record 2 of 5 for:    anatabine

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02432313
First received: April 28, 2015
Last updated: NA
Last verified: April 2015
History: No changes posted
  Purpose

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 Intervention Phase
Pharmacokinetics of Anatabine
Drug: Modified Release Formulation x (MRx)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Rock Creek Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reported adverse events or serious adverse events [ Time Frame: immediately post-dose to 5-days post-dose ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • measures of pro-inflammatory mediators from stimulated peripheral blood mono-nuclear cells [ Time Frame: pre-dose to 12 hours post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: January 2015
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02432313

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

No publications provided

Responsible Party: Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02432313     History of Changes
Other Study ID Numbers: RCP-PK-002
Study First Received: April 28, 2015
Last Updated: April 28, 2015
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on May 26, 2015