Phase 1 Safety and Pharmacokinetics Study of Single Ascending Doses of BTA-C585 in Healthy Volunteers
A Double-Blind, Placebo-Controlled, Single Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers
1 other identifier
interventional
60
1 country
1
Brief Summary
This is a placebo-controlled, double-blind, randomized, single dose escalation Phase 1 clinical trial to determine the safety and tolerability of BTA-C585 administered orally to healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 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
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 22, 2015
CompletedFirst Posted
Study publicly available on registry
September 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMay 30, 2018
May 1, 2018
4 months
September 22, 2015
May 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of adverse events
Day 0 to Day 11
Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours
0-24 hours
Study Arms (2)
BTA-C585 oral capsules
ACTIVE COMPARATOR25 or 100 mg oral capsules; Single ascending doses (SAD) from 50 mg to 800 mg
BTA-C585 matching placebo
PLACEBO COMPARATORBTA-C585 Matching placebo capsules; single doses
Interventions
BTA-C585; Single ascending doses from 50 mg to 800 mg
Single ascending doses to match 50 to 800 mg BTA-C585 capsules
Eligibility Criteria
You may qualify if:
- Healthy men and women aged 18-60 years;
- Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32;
- Female subjects must be of non-childbearing potential;
- Male subjects must agree to use a double barrier method of birth control;
- Able to provide informed consent
You may not qualify if:
- Current or recent (within 14 days of Day 0) bacterial or viral infection;
- Positive results for hepatitis B, hepatitis C, or HIV;
- Clinically significant abnormalities noted on ECG;
- Safety laboratory abnormalities;
- Regular use of medications, prescription or non-prescription;
- Poor vein access or fear of venipuncture;
- 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
September 22, 2015
First Posted
September 24, 2015
Study Start
August 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
May 30, 2018
Record last verified: 2018-05