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

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BBI-5000
Sponsored by
Fresh Tracks Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Celerion Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

BBI-5000 Dose 1

BBI-5000 Dose 2

BBI-5000 Dose 3

BBI-5000 Dose 4

Arm Description

Low dose of BBI-5000

Middle dose of BBI-5000

High dose of BBI-5000

High dose of BBI-5000

Outcomes

Primary Outcome Measures

Plasma concentrations after single dosing of BBI-5000 for BBI-5000 and 3 metabolites
Area Under Curve (AUC) for BBI-5000 and 3 metabolites
Maximum Plasma Concentration (Cmax) for BBI-5000 and 3 metabolites
Time of Occurrence of Cmax (Tmax)
Clearance (CL/F)
Terminal plasma elimination rate constant for BBI-5000 and the 3 metabolites
BBI-5000 concentrations in plasma after dosing in fed and fasted conditions
Half-life for BBI-5000 and the 3 metabolites

Secondary Outcome Measures

Safety and tolerability as measured by assessment of treatment-related adverse events, safety laboratory, vital signs, electrocardiogram and physical examination results

Full Information

First Posted
October 20, 2015
Last Updated
January 18, 2023
Sponsor
Fresh Tracks Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02590289
Brief Title
A Pharmacokinetic Study to Evaluate BBI-5000 Capsules and Food Effect in Healthy Adult Subjects
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresh Tracks Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BBI-5000 Dose 1
Arm Type
Experimental
Arm Description
Low dose of BBI-5000
Arm Title
BBI-5000 Dose 2
Arm Type
Experimental
Arm Description
Middle dose of BBI-5000
Arm Title
BBI-5000 Dose 3
Arm Type
Experimental
Arm Description
High dose of BBI-5000
Arm Title
BBI-5000 Dose 4
Arm Type
Experimental
Arm Description
High dose of BBI-5000
Intervention Type
Drug
Intervention Name(s)
BBI-5000
Intervention Description
BBI-5000 low dose, middle dose, or high doses
Primary Outcome Measure Information:
Title
Plasma concentrations after single dosing of BBI-5000 for BBI-5000 and 3 metabolites
Time Frame
Week 4
Title
Area Under Curve (AUC) for BBI-5000 and 3 metabolites
Time Frame
Week 4
Title
Maximum Plasma Concentration (Cmax) for BBI-5000 and 3 metabolites
Time Frame
Week 4
Title
Time of Occurrence of Cmax (Tmax)
Time Frame
Week 4
Title
Clearance (CL/F)
Time Frame
Week 4
Title
Terminal plasma elimination rate constant for BBI-5000 and the 3 metabolites
Time Frame
Week 4
Title
BBI-5000 concentrations in plasma after dosing in fed and fasted conditions
Time Frame
Week 4
Title
Half-life for BBI-5000 and the 3 metabolites
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
Eosinophil shape change in whole blood as measured by dose and exposure-related dependent changes over time
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Hussey, PharmD
Organizational Affiliation
Fresh Tracks Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Celerion Inc.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68502
Country
United States

12. IPD Sharing Statement

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

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