PharmacokineticsPhase 1NCT02558413
Phase 1 Safety and Pharmacokinetics Study of Single Ascending Doses of BTA-C585 in Healthy Volunteers
A Phase 1 study testing BTA-C585 oral capsules in people with Pharmacokinetics and Healthy Volunteers, run by Biota Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Healthy Volunteers
- What is being tested?
- BTA-C585 oral capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Biota Investigational Site
San Antonio, Texas, 78209
About this study
Official title: A Double-Blind, Placebo-Controlled, Single Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers
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.
- Conditions
- Pharmacokinetics, Healthy Volunteers
- Being tested
- BTA-C585 oral capsules, BTA-C585 matching placebo
- Keywords
- Viral Diseases, Antiviral, Paramyxoviridae Infections, RSV, Respiratory Syncytial Virus, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen
- Medical subject headings
- Virus Diseases, Paramyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTA-C585 oral capsulesDrug
Also called BTA585
BTA-C585; Single ascending doses from 50 mg to 800 mg
BTA-C585 matching placeboDrug
Also called BTA585
Single ascending doses to match 50 to 800 mg BTA-C585 capsules
| Study group | Role | What they receive |
|---|---|---|
| BTA-C585 oral capsules | Active comparator | 25 or 100 mg oral capsules; Single ascending doses (SAD) from 50 mg to 800 mg Receives: Drug: BTA-C585 oral capsules |
| BTA-C585 matching placebo | Placebo comparator | BTA-C585 Matching placebo capsules; single doses Receives: Drug: BTA-C585 matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Measured: Day 0 to Day 11
Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biota Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Novotney-Barry, Study director, Biota Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558413
- Sponsor's protocol ID
- BTA585-001
- Status last verified
- May 2018
- First submitted
- 22 Sep 2015
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Single Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02558413
- Acronym / sponsor ID
- BTA585-001
- Conditions
- Pharmacokinetics, Healthy Volunteers
- Keywords
- Viral Diseases, Antiviral, Paramyxoviridae Infections, RSV, Respiratory Syncytial Virus, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Biota Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTA-C585 oral capsules | Active comparator | Drug: BTA-C585 oral capsules25 or 100 mg oral capsules; Single ascending doses (SAD) from 50 mg to 800 mg |
| BTA-C585 matching placebo | Placebo comparator | Drug: BTA-C585 matching placeboBTA-C585 Matching placebo capsules; single doses |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTA-C585 oral capsulesAlso: BTA585BTA-C585; Single ascending doses from 50 mg to 800 mg | Drug | BTA-C585 oral capsules |
| BTA-C585 matching placeboAlso: BTA585Single ascending doses to match 50 to 800 mg BTA-C585 capsules | Drug | BTA-C585 matching placebo |
Primary outcome
Number of adverse events
Time frame: Day 0 to Day 11
Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours
Time frame: 0-24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Novotney-Barry study director
Biota Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BTA-C585 oral capsules in people with Pharmacokinetics and Healthy Volunteers, run by Biota Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: Day 0 to Day 11). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.