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

Fresh Tracks Therapeutics

Status and phase: Completed; Phase 1

Conditions: Dermatitis, Atopic

Treatments: Drug: BBI-5000

Study type: Interventional

Funder types: Industry

Identifiers

NCT02590289

BBI-5000-CL-103

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

BBI-5000 Dose 1

Experimental group

Description:

Low dose of BBI-5000

Treatment:

Drug: BBI-5000

BBI-5000 Dose 2

Experimental group

Description:

Middle dose of BBI-5000

Treatment:

Drug: BBI-5000

BBI-5000 Dose 3

Experimental group

Description:

High dose of BBI-5000

Treatment:

Drug: BBI-5000

BBI-5000 Dose 4

Experimental group

Description:

High dose of BBI-5000

Treatment:

Drug: BBI-5000