HealthyPhase 1NCT02071121
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect
A Phase 1 study testing BIIB061 and 14C-BIIB061 in people with Healthy, run by Biogen at 2 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of single doses of BIIB061 administered to healthy adult volunteers. Secondary objectives in this study population are to determine the single-dose pharmacokinetic (PK) profile and the absolute bioavailability (Fabs) of BIIB061 and to… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIIB061 and 14C-BIIB061
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2013to Sep 2014
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and postmenopausal (defined as no menses for 12 months and confirmed by follicle-stimulating hormone (FSH) levels determined at screening to be in the postmenopausal range) or surgically sterile females.
- All males must practice effective contraception during the study and be willing and able to continue male contraception for 3 months after the dose of study treatment. All male participants must also be willing to refrain from sperm donation for at least 3 months after their last dose of study treatment. Note: Females of childbearing potential, are not allowed to enter the study.
- Must be in good health and have normal vital signs as determined by the Investigator.
- Participants agree to abstain from alcohol ingestion for the duration of time that they are in the study.
- Must be a nonsmoker and must not use chewing tobacco or nicotine products, for at least 3 months prior to Day -1.
- Must have a body mass index (BMI) of 18 to 30 kg/m2, inclusive.
Who cannot join
- History of or positive test result at screening for human immunodeficiency virus (HIV).
- History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, oncologic, or other major disease, as determined by the Investigator.
- Clinically significant (as determined by the Investigator) 12-lead electrocardiogram (ECG) abnormalities, including corrected QT interval using Fridericia's correction method of >450 ms for males and >470 ms for females.
- History of severe allergic or anaphylactic reactions.
- Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator, within 3 months prior to Day -1.
- Consumption of grapefruit or grapefruit-containing products within 3 days of dosing.
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- Treatment with any over-the-counter products, including herbal and/or alternative health preparations and procedures within the 14 days prior to Day -1.
- Current enrollment in any other drug, biologic, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days (or 5 half-lives, whichever is longer) prior to Day -1.
- Blood donation (1 unit or more) within 30 days prior to Day -1
- History of drug or alcohol abuse (as determined by the Investigator), a positive urine drug/alcohol test, or a positive cotinine test at Screening or Day -1, or alcohol use within 48 hours (as reported by the subject) prior to Day -1.
- Vigorous exercise (as determined by the Investigator) within 48 hours prior to Day -1.
- History of malignant disease, including solid tumors and hematologic malignancies.
- Surgery within 3 months prior to Day-1.
- History of seizures other than childhood febrile seizure.
- Inability or unwillingness to comply with study requirements.
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Evansville, Indiana, 47710
Research Site
Madison, Wisconsin, 53704
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Single-Ascending-Dose (SAD) Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect
The primary objective of this study is to evaluate the safety and tolerability of single doses of BIIB061 administered to healthy adult volunteers. Secondary objectives in this study population are to determine the single-dose pharmacokinetic (PK) profile and the absolute bioavailability (Fabs) of BIIB061 and to determine the effects of food intake (high-fat, high-calorie meal) on BIIB061 PK and safety.
- Conditions
- Healthy
- Being tested
- BIIB061, Placebo, 14C-BIIB061
- Keywords
- BIIB061, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB061Drug
BIIB061 capsules for oral administration
PlaceboDrug
BIIB061 matching placebo capsules
14C-BIIB061Drug
Radiolabeled containing 14C-BIIB061 ≤ 500 nCi.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Fasted participants will receive a single oral dose of placebo to BIIB061. Receives: Drug: Placebo |
| BIIB061 3 mg | Experimental | Fasted participants will receive a single oral dose of BIIB061 3 mg. Receives: Drug: BIIB061 |
| BIIB061 10 mg | Experimental | Fasted participants will receive a single oral dose of BIIB061 10 mg followed by a tracer amount of 14C-BIIB061 (at ≤ 500 nCi/participant; approximately 4 μg of BIIB061), administered by manual slow intravenous push injection at 4 hours postdose. Receives: Drug: BIIB061; Drug: 14C-BIIB061 |
| BIIB061 30 mg | Experimental | Fasted participants will receive a single oral dose of BIIB061 30 mg. Following a washout period, participants will receive the same dose of BIIB061 after a high-fat, high-calorie meal (fed state). Receives: Drug: BIIB061 |
| BIIB061 60 mg | Experimental | Fasted participants will receive a single oral dose of BIIB061 60 mg. Receives: Drug: BIIB061 |
| BIIB061 100 mg | Experimental | Fasted participants will receive a single oral dose of BIIB061 100 mg. Receives: Drug: BIIB061 |
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: 28 days
Secondary outcomes (8)
Area under the concentration-time curve from time 0 to infinity (AUCinf) of BIIB061
Measured: Predose and up to 28 days post-dose.
Maximum observed concentration (Cmax) of BIIB061
Measured: Predose and up to 28 days post-dose.
Time to reach maximum observed concentration (Tmax) of BIIB061
Measured: Predose and up to 28 days post-dose.
Half-life (t1/2) of BIIB061
Measured: Predose and up to 28 days post-dose.
Absolute bioavailability (Fabs) of BIIB061 for the absolute bioavailability cohort only
Measured: Predose and up to 28 days post-dose.
Clearance of BIIB061 for the absolute bioavailability cohort only.
Measured: Predose and up to 28 days post-dose.
Volume of distribution (Vd) of BIIB061 for the absolute bioavailability cohort only.
Measured: Predose and up to 28 days post-dose.
The difference between PK parameters (AUC, Cmax, Tmax, and t1/2) taken under fasting conditions and following a high-fat, high-calorie meal are analyzed
For the fasting PK portion of the study, participants' PK samples are taken after an overnight fast of at least 10 hours. For the food effect portion of the study, the dose is given 30 minutes following a high-fat, high-calorie meal.
Measured: Day 1 to Week 4 (28-day fasting PK measurements), a washout period followed by dosing after a high-fat, high-calorie meal (28-day PK measurements)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 39 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
- NCT02071121
- Sponsor's protocol ID
- 231HV101
- Status last verified
- Oct 2014
- First submitted
- 21 Feb 2014
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled, Single-Ascending-Dose (SAD) Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect
- ClinicalTrials.gov ID
- NCT02071121
- Acronym / sponsor ID
- 231HV101
- Conditions
- Healthy
- Keywords
- BIIB061, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Feb 2014 (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 this study is to evaluate the safety and tolerability of single doses of BIIB061 administered to healthy adult volunteers. Secondary objectives in this study population are to determine the single-dose pharmacokinetic (PK) profile and the absolute bioavailability (Fabs) of BIIB061 and to determine the effects of food intake (high-fat, high-calorie meal) on BIIB061 PK and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboFasted participants will receive a single oral dose of placebo to BIIB061. |
| BIIB061 3 mg | Experimental | Drug: BIIB061Fasted participants will receive a single oral dose of BIIB061 3 mg. |
| BIIB061 10 mg | Experimental | Drug: BIIB061, Drug: 14C-BIIB061Fasted participants will receive a single oral dose of BIIB061 10 mg followed by a tracer amount of 14C-BIIB061 (at ≤ 500 nCi/participant; approximately 4 μg of BIIB061), administered by manual slow intravenous push injection at 4 hours postdose. |
| BIIB061 30 mg | Experimental | Drug: BIIB061Fasted participants will receive a single oral dose of BIIB061 30 mg. Following a washout period, participants will receive the same dose of BIIB061 after a high-fat, high-calorie meal (fed state). |
| BIIB061 60 mg | Experimental | Drug: BIIB061Fasted participants will receive a single oral dose of BIIB061 60 mg. |
| BIIB061 100 mg | Experimental | Drug: BIIB061Fasted participants will receive a single oral dose of BIIB061 100 mg. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males and postmenopausal (defined as no menses for 12 months and confirmed by follicle-stimulating hormone (FSH) levels determined at screening to be in the postmenopausal range) or surgically sterile females.
- All males must practice effective contraception during the study and be willing and able to continue male contraception for 3 months after the dose of study treatment. All male participants must also be willing to refrain from sperm donation for at least 3 months after their last dose of study treatment. Note: Females of childbearing potential, are not allowed to enter the study.
- Must be in good health and have normal vital signs as determined by the Investigator.
- Participants agree to abstain from alcohol ingestion for the duration of time that they are in the study.
- Must be a nonsmoker and must not use chewing tobacco or nicotine products, for at least 3 months prior to Day -1.
Key exclusion criteria (16 listed)
- History of or positive test result at screening for human immunodeficiency virus (HIV).
- History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, oncologic, or other major disease, as determined by the Investigator.
- Clinically significant (as determined by the Investigator) 12-lead electrocardiogram (ECG) abnormalities, including corrected QT interval using Fridericia's correction method of >450 ms for males and >470 ms for females.
- History of severe allergic or anaphylactic reactions.
- Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator, within 3 months prior to 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 |
|---|---|---|
| BIIB061BIIB061 capsules for oral administration | Drug | BIIB061 10 mg, BIIB061 100 mg, BIIB061 3 mg, BIIB061 30 mg, BIIB061 60 mg |
| PlaceboBIIB061 matching placebo capsules | Drug | Placebo |
| 14C-BIIB061Radiolabeled containing 14C-BIIB061 ≤ 500 nCi. | Drug | BIIB061 10 mg |
Primary outcome
Number of participants that experience adverse events (AEs) and Serious Adverse Events (SAEs)
Time frame: 28 days
8 secondary outcomes
Area under the concentration-time curve from time 0 to infinity (AUCinf) of BIIB061
Time frame: Predose and up to 28 days post-dose.
Maximum observed concentration (Cmax) of BIIB061
Time frame: Predose and up to 28 days post-dose.
Time to reach maximum observed concentration (Tmax) of BIIB061
Time frame: Predose and up to 28 days post-dose.
Half-life (t1/2) of BIIB061
Time frame: Predose and up to 28 days post-dose.
Absolute bioavailability (Fabs) of BIIB061 for the absolute bioavailability cohort only
Time frame: Predose and up to 28 days post-dose.
Clearance of BIIB061 for the absolute bioavailability cohort only.
Time frame: Predose and up to 28 days post-dose.
Volume of distribution (Vd) of BIIB061 for the absolute bioavailability cohort only.
Time frame: Predose and up to 28 days post-dose.
The difference between PK parameters (AUC, Cmax, Tmax, and t1/2) taken under fasting conditions and following a high-fat, high-calorie meal are analyzed
Time frame: Day 1 to Week 4 (28-day fasting PK measurements), a washout period followed by dosing after a high-fat, high-calorie meal (28-day PK measurements)
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 2 Feb 2015.
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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.
Medical Director study director
Biogen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIIB061 and 14C-BIIB061 in people with Healthy, run by Biogen at 2 sites 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 6 inclusion and 16 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 2 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 participants that experience adverse events (AEs) and Serious Adverse Events (SAEs) (time frame: 28 days). 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 2 Feb 2015.