Safety and Pharmacokinetics Study of Multiple Ascending Doses of BTA-C585 in Healthy Volunteers
A Sequential-Cohort, Double-Blind, Placebo-Controlled, Multiple Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers
1 other identifier
interventional
36
1 country
1
Brief Summary
This is a single center, sequential-cohort, double-blind, placebo-controlled, multiple ascending dose (MAD), 7-day treatment period study in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2015
Shorter than P25 for phase_1
1 active site
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
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 27, 2016
CompletedFirst Posted
Study publicly available on registry
January 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMay 30, 2018
May 1, 2018
3 months
January 27, 2016
May 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours
0-24 hours
Number of adverse events
Day -1 to Day 14
Study Arms (2)
BTA-C585 oral capsules
ACTIVE COMPARATOR100 mg capsules; Multiple ascending doses (MAD) from 100 mg to 600 mg
BTA-C585 matching placebo
PLACEBO COMPARATORBTA-C585 Matching placebo capsules; single doses
Interventions
BTA-C585; Multiple ascending doses from 100 mg to 600 mg
Multiple ascending doses to match 100 mg to 600 mg BTA-C585 capsules
Eligibility Criteria
You may qualify if:
- Healthy men and women;
- Age 18 to 60 years, inclusive;
- Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32, inclusive;
- Female subjects must be of non-childbearing potential;
- Male subjects must agree to use a double barrier method of birth control;
- Signed informed consent form (ICF) prior to study procedures.
You may not qualify if:
- Current or recent (within 14 days of Day 0) bacterial or viral infection;
- Positive results at screening for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody;
- Clinically significant abnormalities noted on ECG;
- Safety laboratory abnormalities;
- Regular use of medications, prescription or non-prescription;
- Poor vein access or fear of venipuncture or sight of blood;
- Major surgery, significant recent injury or trauma within 30 days;
- Received an investigational drug or vaccine within 30 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Biota Investigational Site
San Antonio, Texas, 78209, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anna Novotney-Barry
Biota Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2016
First Posted
January 29, 2016
Study Start
November 1, 2015
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
May 30, 2018
Record last verified: 2018-05