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

Completed · Phase 1

Conditions studied: Dermatitis, Atopic

In brief

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

Key facts

Study ID

NCT02590289

Run by

Fresh Tracks Therapeutics, Inc.

People needed

20

Starts

2015-10-01

Expected to finish

2015-12-01

Last updated by the study team

2023-01-19

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Celerion Inc. — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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