Healthy ParticipantsPhase 1NCT04138849
Evaluate Safety, Pharmacokinetics and Pharmacodynamics of BBT-877 in Healthy Japanese Male
A Phase 1 study testing BBT-877 single dose in people with Healthy Participants, run by Bridge Biotherapeutics, Inc. at 1 site in United States.
Trial summary
This study will collect safety, pharmacokinetic, and pharmacodynamic data in Japanese male subjects in order to support development worldwide. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BBT-877 single dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 25 Oct 2019
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed the informed consent form as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Healthy male 18 to 55 years of age inclusive at the time of signing the informed consent form
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to dosing and throughout the study.
- Overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests
- Body mass index (BMI) within 18 to 30.0 kg/m2 (inclusive) and body weight not less than 50 kg
- Blood pressure (after supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic.
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- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function.
- Must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least 90 days after dosing of study treatment and refrain from donating sperm during this period
- Be first generation Japanese.
Who cannot join
- Has a history of or current clinically significant medical illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results.
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening and Day -1 as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening and Day -1 as deemed appropriate by the investigator
- Has donated blood or had a significant blood loss (≤500 mL) within 8 weeks of Day 1 or history of anemia or history of decreased red blood cells (RBC).
- Donated plasma within 7 days of Day -1
- Estimated creatinine clearance <80 mL/min
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- Liver function tests (serum alkaline phosphatase [ALP], aspartate transaminase [AST], alanine aminotransferase [ALT]) and serum bilirubin (total and direct) 1.2 times above the upper limit of normal (ULN) at Screening or Day -1.
- Baseline hemoglobin, hematocrit, red blood cell count below the lower limit of normal at Screening and Day -1.
- Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse at screening and Day -1.
- Positive cotinine test at Screening and Day -1.
- History of presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of BBT-877 Following Single Doses in Healthy Japanese Male Subjects
This study will collect safety, pharmacokinetic, and pharmacodynamic data in Japanese male subjects in order to support development worldwide.
- Conditions
- Healthy Participants
- Being tested
- BBT-877 single dose, Placebo single dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBT-877 single doseDrug
Oral capsule, single dose.
Placebo single doseDrug
Oral capsule, single dose.
| Study group | Role | What they receive |
|---|---|---|
| BBT-877 Low Dose | Experimental | Not described Receives: Drug: BBT-877 single dose |
| BBT-877 Mid Dose | Experimental | Not described Receives: Drug: BBT-877 single dose |
| BBT-877 High Dose | Experimental | Not described Receives: Drug: BBT-877 single dose |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
The number of AEs.
Measured: Up to Day 14.
Secondary outcomes (3)
Pharmacokinetics_AUC (the area under the curve)
AUC of BBT-877
Measured: Day 1 to Day 4
Pharmacokinetics_Cmax (peak concentration)
Cmax of BBT-877
Measured: Day 1 to Day 4
Pharmacodynamics_plasma LPA (Lysophosphatidic acid)
plasma LPA (18:2 and 20:4) concentrations over time and percent decrease from baseline LPA level
Measured: Day 1 to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start1 Oct 2019
- Primary completion25 Oct 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bridge Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCRN Research, LLC
- Responsible party
- Sponsor
- Investigators
- Jeong-Hyun Ryou, M.D., Ph.D., Study director, Bridge Biotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138849
- Sponsor's protocol ID
- BBT877-IPF-003
- Status last verified
- Jan 2020
- First submitted
- 23 Oct 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of BBT-877 Following Single Doses in Healthy Japanese Male Subjects
- ClinicalTrials.gov ID
- NCT04138849
- Acronym / sponsor ID
- BBT877-IPF-003
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bridge Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- KCRN Research, LLC
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 25 Oct 2019 (actual)
- 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 study will collect safety, pharmacokinetic, and pharmacodynamic data in Japanese male subjects in order to support development worldwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BBT-877 Low Dose | Experimental | Drug: BBT-877 single dose |
| BBT-877 Mid Dose | Experimental | Drug: BBT-877 single dose |
| BBT-877 High Dose | Experimental | Drug: BBT-877 single dose |
| Placebo | Placebo comparator | Drug: Placebo single dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Signed the informed consent form as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Healthy male 18 to 55 years of age inclusive at the time of signing the informed consent form
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to dosing and throughout the study.
- Overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests
- Body mass index (BMI) within 18 to 30.0 kg/m2 (inclusive) and body weight not less than 50 kg
Key exclusion criteria (12 listed)
- Has a history of or current clinically significant medical illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results.
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening and Day -1 as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening and Day -1 as deemed appropriate by the investigator
- Has donated blood or had a significant blood loss (≤500 mL) within 8 weeks of Day 1 or history of anemia or history of decreased red blood cells (RBC).
- Donated plasma within 7 days of Day -1
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 |
|---|---|---|
| BBT-877 single doseOral capsule, single dose. | Drug | BBT-877 High Dose, BBT-877 Low Dose, BBT-877 Mid Dose |
| Placebo single doseOral capsule, single dose. | Drug | Placebo |
Primary outcome
Adverse events (AEs)
Time frame: Up to Day 14.
The number of AEs.
3 secondary outcomes
Pharmacokinetics_AUC (the area under the curve)
Time frame: Day 1 to Day 4
Pharmacokinetics_Cmax (peak concentration)
Time frame: Day 1 to Day 4
Pharmacodynamics_plasma LPA (Lysophosphatidic acid)
Time frame: Day 1 to Day 4
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 18 Jan 2020.
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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.
Jeong-Hyun Ryou, M.D., Ph.D. study director
Bridge Biotherapeutics, 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 BBT-877 single dose in people with Healthy Participants, run by Bridge Biotherapeutics, 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 9 inclusion and 12 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 18 Jan 2020. 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?
Adverse events (AEs) (time frame: Up to Day 14.). 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 18 Jan 2020.