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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brickell Biotech, Inc.

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