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

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590289
• Other study ID #: BBI-5000-CL-103
• Status: Completed
• Phase: Phase 1
• Start date: October 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2023
• Source: Fresh Tracks Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Drug:
• BBI-5000
BBI-5000 low dose, middle dose, or high doses

Locations

Country	Name	City	State
United States	Celerion Inc.	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Fresh Tracks Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Eosinophil shape change in whole blood as measured by dose and exposure-related dependent changes over time		Week 4
Primary	Plasma concentrations after single dosing of BBI-5000 for BBI-5000 and 3 metabolites		Week 4
Primary	Area Under Curve (AUC) for BBI-5000 and 3 metabolites		Week 4
Primary	Maximum Plasma Concentration (Cmax) for BBI-5000 and 3 metabolites		Week 4
Primary	Time of Occurrence of Cmax (Tmax)		Week 4
Primary	Clearance (CL/F)		Week 4
Primary	Terminal plasma elimination rate constant for BBI-5000 and the 3 metabolites		Week 4
Primary	BBI-5000 concentrations in plasma after dosing in fed and fasted conditions		Week 4
Primary	Half-life for BBI-5000 and the 3 metabolites		Week 4
Secondary	Safety and tolerability as measured by assessment of treatment-related adverse events, safety laboratory, vital signs, electrocardiogram and physical examination results		Week 4