NCT02590289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

October 20, 2015

Last Update Submit

January 18, 2023

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (8)

  • Plasma concentrations after single dosing of BBI-5000 for BBI-5000 and 3 metabolites

    Week 4

  • Area Under Curve (AUC) for BBI-5000 and 3 metabolites

    Week 4

  • Maximum Plasma Concentration (Cmax) for BBI-5000 and 3 metabolites

    Week 4

  • Time of Occurrence of Cmax (Tmax)

    Week 4

  • Clearance (CL/F)

    Week 4

  • Terminal plasma elimination rate constant for BBI-5000 and the 3 metabolites

    Week 4

  • BBI-5000 concentrations in plasma after dosing in fed and fasted conditions

    Week 4

  • Half-life for BBI-5000 and the 3 metabolites

    Week 4

Secondary Outcomes (1)

  • Safety and tolerability as measured by assessment of treatment-related adverse events, safety laboratory, vital signs, electrocardiogram and physical examination results

    Week 4

Other Outcomes (1)

  • Eosinophil shape change in whole blood as measured by dose and exposure-related dependent changes over time

    Week 4

Study Arms (4)

BBI-5000 Dose 1

EXPERIMENTAL

Low dose of BBI-5000

Drug: BBI-5000

BBI-5000 Dose 2

EXPERIMENTAL

Middle dose of BBI-5000

Drug: BBI-5000

BBI-5000 Dose 3

EXPERIMENTAL

High dose of BBI-5000

Drug: BBI-5000

BBI-5000 Dose 4

EXPERIMENTAL

High dose of BBI-5000

Drug: BBI-5000

Interventions

BBI-5000DRUG

BBI-5000 low dose, middle dose, or high doses

BBI-5000 Dose 1BBI-5000 Dose 2BBI-5000 Dose 3BBI-5000 Dose 4

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non-smoker
  • Medically healthy
  • \>= 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion Inc.

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Elizabeth Hussey, PharmD

    Fresh Tracks Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2015

First Posted

October 29, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 19, 2023

Record last verified: 2023-01

Locations

US(1)