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A Pharmacokinetic Study to Evaluate BBI-5000 Capsules and Food Effect in Healthy Adult Subjects

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: NCT02590289
Recruitment Status : Completed
First Posted : October 29, 2015
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Brickell Biotech, Inc.

Tracking Information
First Submitted Date  ICMJE October 20, 2015
First Posted Date  ICMJE October 29, 2015
Last Update Posted Date December 2, 2015
Study Start Date  ICMJE October 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
  • Plasma concentrations after single dosing of BBI-5000 for BBI-5000 and 3 metabolites [ Time Frame: Week 4 ]
  • Area Under Curve (AUC) for BBI-5000 and 3 metabolites [ Time Frame: Week 4 ]
  • Maximum Plasma Concentration (Cmax) for BBI-5000 and 3 metabolites [ Time Frame: Week 4 ]
  • Time of Occurrence of Cmax (Tmax) [ Time Frame: Week 4 ]
  • Clearance (CL/F) [ Time Frame: Week 4 ]
  • Terminal plasma elimination rate constant for BBI-5000 and the 3 metabolites [ Time Frame: Week 4 ]
  • BBI-5000 concentrations in plasma after dosing in fed and fasted conditions [ Time Frame: Week 4 ]
  • Half-life for BBI-5000 and the 3 metabolites [ Time Frame: Week 4 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
Safety and tolerability as measured by assessment of treatment-related adverse events, safety laboratory, vital signs, electrocardiogram and physical examination results [ Time Frame: Week 4 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 27, 2015)
Eosinophil shape change in whole blood as measured by dose and exposure-related dependent changes over time [ Time Frame: Week 4 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Pharmacokinetic Study to Evaluate BBI-5000 Capsules and Food Effect in Healthy Adult Subjects
Official Title  ICMJE An Open-Label, Single-Dose, 4-Way Crossover, Bioavailability Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Food Effect of BBI-5000 Capsules in Healthy Adult Subjects
Brief Summary To assess the pharmacokinetics of 3 doses and the food effect of a single high dose of BBI-5000 capsules in healthy adult subjects.
Detailed Description

This is an open-label, randomized, 4-period, 4-way crossover, 4-sequence study to evaluate the pharmacokinetics (PK) and food effect of BBI-5000 capsules in healthy adult subjects.

Participating subjects will receive a single oral dose of BBI-5000 followed by a washout period of 7-14 days between doses. The treatment period will be followed by 5-10 day follow-up period.

PK and PD will be assessed by blood sampling through 72 hours postdose.

Safety will be assessed through collection of vital signs, adverse events, physical examination, ECGs and clinical laboratory tests.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dermatitis, Atopic
Intervention  ICMJE Drug: BBI-5000
BBI-5000 low dose, middle dose, or high doses
Study Arms  ICMJE
  • Experimental: BBI-5000 Dose 1
    Low dose of BBI-5000
    Intervention: Drug: BBI-5000
  • Experimental: BBI-5000 Dose 2
    Middle dose of BBI-5000
    Intervention: Drug: BBI-5000
  • Experimental: BBI-5000 Dose 3
    High dose of BBI-5000
    Intervention: Drug: BBI-5000
  • Experimental: BBI-5000 Dose 4
    High dose of BBI-5000
    Intervention: Drug: BBI-5000
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: October 27, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non-smoker
  • Medically healthy
  • 32.0 >= BMI >= 18.5 kg/m^2
  • Weight >= 50 kg for males
  • Weight >= 45 kg for females
  • For a female of childbearing potential: either be sexually inactive for 14 days prior to the first dose and throughout the study or be using an acceptable birth control method as dictated by the study
  • Willing to comply with protocol and understands study procedures outlined in the ICF

Exclusion Criteria:

  • Subject is mentally or legally incapacitated or has significant emotional problems
  • History or presence of medical or psychiatric disease
  • History of any illness that might confound the results of the study
  • History or presence of alcoholism or drug abuse
  • History or presence of hypersensitivity or idiosyncratic reaction the the study drug excipient
  • History or presence of lactose intolerance
  • Pregnant or lactating females
  • Seated blood pressure less than 90/40 mmHg or greater than 140/90 mmHg
  • Seated heart rate lower than 40 bpm or higher than 99 bpm
  • Unable to refrain from or anticipates the use of any drug
  • Diet incompatible with the on-study diet
  • Donation of blood or significant blood loss within 56 days prior to the first study dose
  • Participation in another clinical trial within 28 days prior to the first study dose
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02590289
Other Study ID Numbers  ICMJE BBI-5000-CL-103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brickell Biotech, Inc.
Study Sponsor  ICMJE Brickell Biotech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Elizabeth Hussey, PharmD Brickell Biotech, Inc.
PRS Account Brickell Biotech, Inc.
Verification Date December 2015

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