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Trial record 1 of 1 for:    BBI-5000
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A Pharmacokinetic Study to Evaluate BBI-5000 Capsules and Food Effect in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT02590289
Recruitment Status : Completed
First Posted : October 29, 2015
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Brickell Biotech, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: BBI-5000 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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




Primary Outcome Measures :
  1. Plasma concentrations after single dosing of BBI-5000 for BBI-5000 and 3 metabolites [ Time Frame: Week 4 ]
  2. Area Under Curve (AUC) for BBI-5000 and 3 metabolites [ Time Frame: Week 4 ]
  3. Maximum Plasma Concentration (Cmax) for BBI-5000 and 3 metabolites [ Time Frame: Week 4 ]
  4. Time of Occurrence of Cmax (Tmax) [ Time Frame: Week 4 ]
  5. Clearance (CL/F) [ Time Frame: Week 4 ]
  6. Terminal plasma elimination rate constant for BBI-5000 and the 3 metabolites [ Time Frame: Week 4 ]
  7. BBI-5000 concentrations in plasma after dosing in fed and fasted conditions [ Time Frame: Week 4 ]
  8. Half-life for BBI-5000 and the 3 metabolites [ Time Frame: Week 4 ]

Secondary Outcome Measures :
  1. Safety and tolerability as measured by assessment of treatment-related adverse events, safety laboratory, vital signs, electrocardiogram and physical examination results [ Time Frame: Week 4 ]

Other Outcome Measures:
  1. Eosinophil shape change in whole blood as measured by dose and exposure-related dependent changes over time [ Time Frame: Week 4 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590289


Locations
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United States, Nebraska
Celerion Inc.
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Brickell Biotech, Inc.
Investigators
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Study Director: Elizabeth Hussey, PharmD Brickell Biotech, Inc.
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Responsible Party: Brickell Biotech, Inc.
ClinicalTrials.gov Identifier: NCT02590289    
Other Study ID Numbers: BBI-5000-CL-103
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases