Systemic Lupos Erythematosus, SLEPhase 1NCT02829541
A Phase 1, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic(PK), and Pharmacodynamic(PD) Study of BIIB068 in Healthy Participants
A Phase 1 study testing BIIB068 in people with Systemic Lupos Erythematosus, SLE, run by Biogen at 1 site in United States.
Trial summary
The primary objective of the study is to evaluate the safety and tolerability of single oral doses of BIIB068 in healthy participants. Secondary objectives are to characterize the single-oral-dose Pharmacokinetic (PK) of BIIB068 in healthy participants, to determine the effect of food on the single-oral-dose PK of… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupos Erythematosus, SLE
- What is being tested?
- BIIB068
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2016
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All male subjects must practice highly effective methods of contraception during the study and be willing and able to continue contraception and not donate sperm for at least 1 spermatogenic cycle (90 days) after administration of last dose of study treatment.
- All female subjects of childbearing potential must practice highly effective methods of contraception during the study and be willing and able to continue contraception for at least 1ovulatory cycle (30 days) after their last dose of study treatment.
- Must have a body mass index (BMI) between 18 and 32 kg/m2
- Must be in good health as determined by the Investigator, based on medical history and screening evaluations.
Who cannot join
- History of any clinically significant cardiac, endocrine, gastrointestinal (GI), hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- History of severe allergic or anaphylactic reactions, or history of any allergic reactions that in the opinion of the Investigator is likely to be exacerbated by any component of the study treatment.
- Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day-1.
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB068, a Bruton's Tyrosine Kinase Inhibitor, in Healthy Subjects
The primary objective of the study is to evaluate the safety and tolerability of single oral doses of BIIB068 in healthy participants. Secondary objectives are to characterize the single-oral-dose Pharmacokinetic (PK) of BIIB068 in healthy participants, to determine the effect of food on the single-oral-dose PK of BIIB068 in healthy participants and to examine the effect of administration of the proton pump inhibitor (PPI) esomeprazole on the single-dose PK of BIIB068 in healthy participants.
- Conditions
- Systemic Lupos Erythematosus, SLE
- Being tested
- BIIB068, Placebo
- Keywords
- Single Ascending Dose (SAD), Healthy Volunteers
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB068Drug
Also called Bruton's tyrosine kinase (BTK)
Administered as specified in the treatment arm.
PlaceboDrug
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Cohorts 1 | Experimental | 6 participants randomized (4:2) to receive a single-ascending dose (SAD) administered orally in tablet Receives: Drug: BIIB068; Drug: Placebo |
| Cohort 2 | Experimental | 6 participants randomized (4:2) to receive a SAD administered orally in tablet(s) Receives: Drug: BIIB068; Drug: Placebo |
| Cohort 3 | Experimental | 8 participants randomized (6:2) to receive a SAD administered orally in tablet(s) Receives: Drug: BIIB068; Drug: Placebo |
| Cohort 4 | Experimental | 8 participants randomized (6:2) to receive a SAD administered orally in tablet Receives: Drug: BIIB068; Drug: Placebo |
| Cohort 5 | Experimental | 8 participants randomized (6:2) to receive a SAD administered orally in tablet(s) Receives: Drug: BIIB068; Drug: Placebo |
| Cohort 6 | Experimental | 14 participants (all active) to receive a SAD administered orally in tablet(s) Receives: Drug: BIIB068 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to 9 Days Post dose
Number of participants with clinically significant laboratory assessment abnormalities
Measured: Up to 9 Days Post dose
Number of participants with clinically significant Vital sign abnormalities
Measured: Up to 9 Days Post dose
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Measured: Up to 9 Days Post dose
Number of participants with clinically significant physical examination abnormalities
Measured: Up to 9 Days Post dose
Secondary outcomes (10)
PK Assessment - Area Under the concentration-time curve from time zero to time of the Last Measurable Concentration (AUC0-tlast)
Measured: Up to 48 Hours Post dose
PK Assessment - Area under the concentration-time curve from time 0 to infinity (AUCinf)
Measured: Up to 48 Hours Post dose
PK Assessment - Maximum observed concentration (Cmax)
Measured: Up to 48 Hours Post dose
PK Assessment - Time to reach maximum observed concentration (Tmax)
Measured: Up to 48 Hours Post dose
PK Assessment - Terminal elimination half-life (t1/2)
Measured: Up to 48 Hours Post dose
PK Assessment - Apparent total body clearance (CL/F)
Measured: Up to 48 Hours Post dose
PK Assessment - Apparent volume of distribution (Vz/F)
Measured: Up to 48 Hours Post dose
PK Assessment - Amount of BIIB068 excreted in urine (Aeu)
Measured: Up to 48 Hours Post dose
PK Assessment - Percentage (%fe) of BIIB068 excreted in urine
Measured: Up to 48 Hours Post dose
PK Assessment - Renal clearance (CLr)
Measured: Up to 48 Hours Post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupos Erythematosus, SLEStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829541
- Sponsor's protocol ID
- 236HV101
- Status last verified
- Mar 2017
- First submitted
- 8 Jul 2016
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB068, a Bruton's Tyrosine Kinase Inhibitor, in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02829541
- Acronym / sponsor ID
- 236HV101
- Conditions
- Systemic Lupos Erythematosus, SLE
- Keywords
- Single Ascending Dose (SAD), Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Jul 2016 (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.
The primary objective of the study is to evaluate the safety and tolerability of single oral doses of BIIB068 in healthy participants. Secondary objectives are to characterize the single-oral-dose Pharmacokinetic (PK) of BIIB068 in healthy participants, to determine the effect of food on the single-oral-dose PK of BIIB068 in healthy participants and to examine the effect of administration of the proton pump inhibitor (PPI) esomeprazole on the single-dose PK of BIIB068 in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohorts 1 | Experimental | Drug: BIIB068, Drug: Placebo6 participants randomized (4:2) to receive a single-ascending dose (SAD) administered orally in tablet |
| Cohort 2 | Experimental | Drug: BIIB068, Drug: Placebo6 participants randomized (4:2) to receive a SAD administered orally in tablet(s) |
| Cohort 3 | Experimental | Drug: BIIB068, Drug: Placebo8 participants randomized (6:2) to receive a SAD administered orally in tablet(s) |
| Cohort 4 | Experimental | Drug: BIIB068, Drug: Placebo8 participants randomized (6:2) to receive a SAD administered orally in tablet |
| Cohort 5 | Experimental | Drug: BIIB068, Drug: Placebo8 participants randomized (6:2) to receive a SAD administered orally in tablet(s) |
| Cohort 6 | Experimental | Drug: BIIB06814 participants (all active) to receive a SAD administered orally in tablet(s) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All male subjects must practice highly effective methods of contraception during the study and be willing and able to continue contraception and not donate sperm for at least 1 spermatogenic cycle (90 days) after administration of last dose of study treatment.
- All female subjects of childbearing potential must practice highly effective methods of contraception during the study and be willing and able to continue contraception for at least 1ovulatory cycle (30 days) after their last dose of study treatment.
- Must have a body mass index (BMI) between 18 and 32 kg/m2
- Must be in good health as determined by the Investigator, based on medical history and screening evaluations.
Key exclusion criteria (4 listed)
- History of any clinically significant cardiac, endocrine, gastrointestinal (GI), hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- History of severe allergic or anaphylactic reactions, or history of any allergic reactions that in the opinion of the Investigator is likely to be exacerbated by any component of the study treatment.
- Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day-1.
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| BIIB068Also: Bruton's tyrosine kinase (BTK)Administered as specified in the treatment arm. | Drug | Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohorts 1 |
| PlaceboAdministered as specified in the treatment arm | Drug | Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohorts 1 |
Primary outcome
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 9 Days Post dose
Number of participants with clinically significant laboratory assessment abnormalities
Time frame: Up to 9 Days Post dose
Number of participants with clinically significant Vital sign abnormalities
Time frame: Up to 9 Days Post dose
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time frame: Up to 9 Days Post dose
Number of participants with clinically significant physical examination abnormalities
Time frame: Up to 9 Days Post dose
10 secondary outcomes
PK Assessment - Area Under the concentration-time curve from time zero to time of the Last Measurable Concentration (AUC0-tlast)
Time frame: Up to 48 Hours Post dose
PK Assessment - Area under the concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Up to 48 Hours Post dose
PK Assessment - Maximum observed concentration (Cmax)
Time frame: Up to 48 Hours Post dose
PK Assessment - Time to reach maximum observed concentration (Tmax)
Time frame: Up to 48 Hours Post dose
PK Assessment - Terminal elimination half-life (t1/2)
Time frame: Up to 48 Hours Post dose
PK Assessment - Apparent total body clearance (CL/F)
Time frame: Up to 48 Hours Post dose
PK Assessment - Apparent volume of distribution (Vz/F)
Time frame: Up to 48 Hours Post dose
PK Assessment - Amount of BIIB068 excreted in urine (Aeu)
Time frame: Up to 48 Hours Post dose
PK Assessment - Percentage (%fe) of BIIB068 excreted in urine
Time frame: Up to 48 Hours Post dose
PK Assessment - Renal clearance (CLr)
Time frame: Up to 48 Hours Post dose
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 15 Mar 2017.
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.
Medical Director study director
Biogen
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 BIIB068 in people with Systemic Lupos Erythematosus, SLE, run by Biogen 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 4 inclusion and 4 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 15 Mar 2017. 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. 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 participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 9 Days Post dose). The study lists 5 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 15 Mar 2017.