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

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

To assess the pharmacokinetics of 3 doses and the food effect of a single high dose of BBI-5000 capsules in healthy adult subjects.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: BBI-5000

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: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BBI-5000 Dose 1; Low dose of BBI-5000	Drug: BBI-5000; BBI-5000 low dose, middle dose, or high doses
Experimental: BBI-5000 Dose 2; Middle dose of BBI-5000	Drug: BBI-5000; BBI-5000 low dose, middle dose, or high doses
Experimental: BBI-5000 Dose 3; High dose of BBI-5000	Drug: BBI-5000; BBI-5000 low dose, middle dose, or high doses
Experimental: BBI-5000 Dose 4; High dose of BBI-5000	Drug: BBI-5000; BBI-5000 low dose, middle dose, or high doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma concentrations after single dosing of BBI-5000 for BBI-5000 and 3 metabolites	Week 4
Area Under Curve (AUC) for BBI-5000 and 3 metabolites	Week 4
Maximum Plasma Concentration (Cmax) for BBI-5000 and 3 metabolites	Week 4
Time of Occurrence of Cmax (Tmax)	Week 4
Clearance (CL/F)	Week 4
Terminal plasma elimination rate constant for BBI-5000 and the 3 metabolites	Week 4
BBI-5000 concentrations in plasma after dosing in fed and fasted conditions	Week 4
Half-life for BBI-5000 and the 3 metabolites	Week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability as measured by assessment of treatment-related adverse events, safety laboratory, vital signs, electrocardiogram and physical examination results	Week 4

Other Outcome Measures

Outcome Measure	Time Frame
Eosinophil shape change in whole blood as measured by dose and exposure-related dependent changes over time	Week 4

Collaborators and Investigators

• Sponsor: Fresh Tracks Therapeutics, Inc.
• Investigators: Study Director: Elizabeth Hussey, PharmD, Fresh Tracks Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimate): October 29, 2015

Study Record Updates

• Last Update Posted (Actual): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic
• Other Study ID Numbers: BBI-5000-CL-103