Drug InteractionsPhase 1NCT03324685
A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen
A Phase 1 study testing BIIB074 and OC (ethinyl estradiol and levonorgestrel) in people with Drug Interactions, run by Biogen at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the effect of multiple doses of a uridine diphosphate glucuronosyltransferases (UGT)-inducing oral contraceptive (OC) regimen (ethinyl estradiol and levonorgestrel) on the PK of BIIB074 at steady state; evaluate the effect of multiple doses of BIIB074 on the… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Interactions
- What is being tested?
- BIIB074 and OC (ethinyl estradiol and levonorgestrel)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2017to 15 Mar 2018
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have a body mass index between 18 and 32 kg/m^2, inclusive.
- Females of childbearing potential must practice effective non-hormonal contraception during the study and be willing and able to continue contraception for 5 weeks after their last dose of study treatment,
- 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, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- History of, or positive test result at Screening for, human immunodeficiency virus (HIV)
- Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day -1
- Previous intolerance to OC medications
- Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment.
- 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 Study to Evaluate the Pharmacokinetic Interaction Potential Between BIIB074 and an Oral Contraceptive Regimen in Healthy Female Subjects
The primary objective of this study is to evaluate the effect of multiple doses of a uridine diphosphate glucuronosyltransferases (UGT)-inducing oral contraceptive (OC) regimen (ethinyl estradiol and levonorgestrel) on the PK of BIIB074 at steady state; evaluate the effect of multiple doses of BIIB074 on the pharmacokinetics(PK) of an OC regimen (ethinyl estradiol and levonorgestrel) at steady state.
The secondary objective of this study is to evaluate the safety and tolerability of BIIB074 when administered alone and when coadministered with a UGT-inducing OC regimen containing ethinyl estradiol and levonorgestrel and to evaluate the effect of a UGT-inducing OC regimen (ethinyl estradiol and levonorgestrel) on the PK of the M13, M14, and M16 metabolites of BIIB074.
- Conditions
- Drug Interactions
- Being tested
- BIIB074, OC (ethinyl estradiol and levonorgestrel)
- Keywords
- Oral Contraceptive, Healthy Volunteers, Ethinyl Estradiol,, Levonorgestrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB074Drug
BIIB074 is administered as specified in the treatment arm.
OC (ethinyl estradiol and levonorgestrel)Drug
OC is administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| BIIB074 150 mg and Oral Contraceptive | Experimental | Participants will receive BIIB074 in tablet form in 150 mg doses every 8 hours on prescription (TID) on days 1-7 and on days 26-32. OC will be taken in tablet form (ethinyl estradiol 30 micrograms and levonorgestrel 150 micrograms) once daily (QD) on days 12-32. Receives: Drug: BIIB074; Drug: OC (ethinyl estradiol and levonorgestrel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve from Hour 0 to Hour 8 (AUC8) for BIIB074
Measured: Day 7, 32
Area Under the Concentration-Time Curve from Hour 0 to Hour 24 (AUC24) for OC
Measured: Day 25, 32
Maximum Observed Concentration (Cmax) for BIIB074
Measured: Day 7, 32
Maximum Observed Concentration (Cmax) for OC
Measured: Day 25, 32
Time to Reach Maximum Observed Concentration (Tmax) for BIIB074
Measured: Day 7, 32
Terminal Elimination Half-Life (t1/2) of BIIB074
Measured: Day 7, 32
Apparent Clearance (CL/F) for BIIB074
Measured: Day 7, 32
Apparent Volume of Distribution at Steady State (Vss/F) for BIIB074
Measured: Day 7, 32
Time to Maximum Observed Concentration (Tmax) for OC
Measured: Day 25, 32
Terminal Elimination Half-Life (t1/2) of OC
Measured: Day 25, 32
Apparent Clearance (CL/F) for OC
Measured: Day 25, 32
Apparent Volume of Distribution at Steady State (Vss/F) for OC
Measured: Day 25, 32
Secondary outcomes (13)
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
Measured: Approximately 71 days
Number of Participants with Abnormal Change from Baseline in Laboratory Parameters up to Day 33
Chemistry panel included total protein, albumin, creatinine, blood urea nitrogen, uric acid, bilirubin (total and direct), alkaline phosphatase, ALT, AST, gamma-glutamyl transferase, glucose, calcium, phosphorus, bicarbonate, chloride, sodium, and potassium.
Measured: Day 3, 7, 24, 28, 33
Number of Participants with Abnormal Change from Baseline in Hematology Panel up to Day 33
Hematology Panel measurements are complete blood count with differential and platelet count, and absolute neutrophil count
Measured: Day 3, 7, 24, 28, 33
Number of Participants with Abnormal Change from Baseline in Urinalysis Panel up to Day 33
Urinalysis panel included dipstick for occult blood, protein, nitrites, leukocyte esterase, glucose, bilirubin, urobilinogen, ketones, pH, and specific gravity. A microscopic examination will be performed if occult blood, protein, nitrites, or leukocyte esterase is abnormal.
Measured: Day 3, 7, 24, 28, 33
Number of Participants with Abnormal Change from Baseline in Vital Sign Measurements up to Day 33
Vital signs measurements are temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate
Measured: Day 1, 3, 7, 12, 24, 25, 26, 28, 33
Number of Participants with Abnormal Change from Baseline in Electrocardiogram (ECG) up to Day 33
12-lead ECGs measurements are heart rate, PR interval, RR interval, QRS duration, QT interval, and QTcF
Measured: Day 1, 3, 7, 12, 25, 26, 28, 33
Number of Participants with Abnormal Change from Baseline in Physical Examination up to Day 33
Abnormal physical examinations findings that are noted postbaseline and deemed clinically significant by the Investigator will be reported as AEs and will be included in the AE analyses.
Measured: Day -1, 33
AUC 8 of BIIB074 Metabolites M13, M14, and M16
AUC8 indicates the actual body exposure to BIIB074 metabolites during 8 hours after administration of a BIIB074 dose and is expressed in mg*h/L.
Measured: Day 7, 32
Cmax for BIIB074 Metabolites M13, M14, and M16
Cmax is the maximum serum concentration that BIIB074 metabolites M13, 14, and 16 achieves in the body after BIIB074 is administered.
Measured: Day 7, 32
Tmax for BIIB074 Metabolites M13, M14, and M16
Tmax is the amount of time it takes to reach Cmax of the BIIB074 metabolites13,14, and 16 after BIIB074 has been administered.
Measured: Day 7, 32
Terminal Elimination Half-Life (T 1/2) for BIIB074 Metabolites M13, M14, and M16
The terminal elimination half-life is the time required to divide the plasma concentration of BIIB074 metabolites M13,14,and 16 by two after reaching pseudo-equilibrium.
Measured: Day 7, 32
Metabolite-to-Parent Ratio in AUC (MRauc) for BIIB074 Metabolites M13, M14, and M16
The MRauc is the ratio of the BIIB074 metabolites M13,14,and 16 to BIIB074 after administration
Measured: Day 7, 32
Number of Participants with Abnormal Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Assessments
The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period.
Measured: Day 7, 12, 24, 33, and once between Day 39-42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start11 Nov 2017
- Primary completion15 Mar 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug InteractionsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT03324685
- Sponsor's protocol ID
- 802HV108
- Status last verified
- Sep 2018
- First submitted
- 25 Oct 2017
- Last updated
- 25 Sep 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Zhao Y, Versavel M, Tidemann-Miller B, Christmann R, Naik H. Evaluation of the Potential Pharmacokinetic Interactions Between Vixotrigine and an Oral Contraceptive. Clin Drug Investig. 2020 Aug;40(8):737-746. doi: 10.1007/s40261-020-00931-5.
PubMed 32564301
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Pharmacokinetic Interaction Potential Between BIIB074 and an Oral Contraceptive Regimen in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT03324685
- Acronym / sponsor ID
- 802HV108
- Conditions
- Drug Interactions
- Keywords
- Oral Contraceptive, Healthy Volunteers, Ethinyl Estradiol,, Levonorgestrel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2017 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 30 Oct 2017 (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.
The primary objective of this study is to evaluate the effect of multiple doses of a uridine diphosphate glucuronosyltransferases (UGT)-inducing oral contraceptive (OC) regimen (ethinyl estradiol and levonorgestrel) on the PK of BIIB074 at steady state; evaluate the effect of multiple doses of BIIB074 on the pharmacokinetics(PK) of an OC regimen (ethinyl estradiol and levonorgestrel) at steady state.
The secondary objective of this study is to evaluate the safety and tolerability of BIIB074 when administered alone and when coadministered with a UGT-inducing OC regimen containing ethinyl estradiol and levonorgestrel and to evaluate the effect of a UGT-inducing OC regimen (ethinyl estradiol and levonorgestrel) on the PK of the M13, M14, and M16 metabolites of BIIB074.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIIB074 150 mg and Oral Contraceptive | Experimental | Drug: BIIB074, Drug: OC (ethinyl estradiol and levonorgestrel)Participants will receive BIIB074 in tablet form in 150 mg doses every 8 hours on prescription (TID) on days 1-7 and on days 26-32. OC will be taken in tablet form (ethinyl estradiol 30 micrograms and levonorgestrel 150 micrograms) once daily (QD) on days 12-32. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must have a body mass index between 18 and 32 kg/m^2, inclusive.
- Females of childbearing potential must practice effective non-hormonal contraception during the study and be willing and able to continue contraception for 5 weeks after their last dose of study treatment,
- Must be in good health as determined by the Investigator, based on medical history and screening evaluations.
Key exclusion criteria (6 listed)
- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- History of, or positive test result at Screening for, human immunodeficiency virus (HIV)
- Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day -1
- Previous intolerance to OC medications
- Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment.
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 |
|---|---|---|
| BIIB074BIIB074 is administered as specified in the treatment arm. | Drug | BIIB074 150 mg and Oral Contraceptive |
| OC (ethinyl estradiol and levonorgestrel)OC is administered as specified in the treatment arm. | Drug | BIIB074 150 mg and Oral Contraceptive |
Primary outcome
Area Under the Concentration-Time Curve from Hour 0 to Hour 8 (AUC8) for BIIB074
Time frame: Day 7, 32
Area Under the Concentration-Time Curve from Hour 0 to Hour 24 (AUC24) for OC
Time frame: Day 25, 32
Maximum Observed Concentration (Cmax) for BIIB074
Time frame: Day 7, 32
Maximum Observed Concentration (Cmax) for OC
Time frame: Day 25, 32
Time to Reach Maximum Observed Concentration (Tmax) for BIIB074
Time frame: Day 7, 32
Terminal Elimination Half-Life (t1/2) of BIIB074
Time frame: Day 7, 32
Apparent Clearance (CL/F) for BIIB074
Time frame: Day 7, 32
Apparent Volume of Distribution at Steady State (Vss/F) for BIIB074
Time frame: Day 7, 32
Time to Maximum Observed Concentration (Tmax) for OC
Time frame: Day 25, 32
Terminal Elimination Half-Life (t1/2) of OC
Time frame: Day 25, 32
Apparent Clearance (CL/F) for OC
Time frame: Day 25, 32
Apparent Volume of Distribution at Steady State (Vss/F) for OC
Time frame: Day 25, 32
13 secondary outcomes
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Approximately 71 days
Number of Participants with Abnormal Change from Baseline in Laboratory Parameters up to Day 33
Time frame: Day 3, 7, 24, 28, 33
Number of Participants with Abnormal Change from Baseline in Hematology Panel up to Day 33
Time frame: Day 3, 7, 24, 28, 33
Number of Participants with Abnormal Change from Baseline in Urinalysis Panel up to Day 33
Time frame: Day 3, 7, 24, 28, 33
Number of Participants with Abnormal Change from Baseline in Vital Sign Measurements up to Day 33
Time frame: Day 1, 3, 7, 12, 24, 25, 26, 28, 33
Number of Participants with Abnormal Change from Baseline in Electrocardiogram (ECG) up to Day 33
Time frame: Day 1, 3, 7, 12, 25, 26, 28, 33
Number of Participants with Abnormal Change from Baseline in Physical Examination up to Day 33
Time frame: Day -1, 33
AUC 8 of BIIB074 Metabolites M13, M14, and M16
Time frame: Day 7, 32
Cmax for BIIB074 Metabolites M13, M14, and M16
Time frame: Day 7, 32
Tmax for BIIB074 Metabolites M13, M14, and M16
Time frame: Day 7, 32
Terminal Elimination Half-Life (T 1/2) for BIIB074 Metabolites M13, M14, and M16
Time frame: Day 7, 32
Metabolite-to-Parent Ratio in AUC (MRauc) for BIIB074 Metabolites M13, M14, and M16
Time frame: Day 7, 32
Number of Participants with Abnormal Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Assessments
Time frame: Day 7, 12, 24, 33, and once between Day 39-42
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 25 Sep 2018.
- Derived from this study: PubMed 32564301Zhao Y, Versavel M, Tidemann-Miller B, Christmann R, Naik H. Evaluation of the Potential Pharmacokinetic Interactions Between Vixotrigine and an Oral Contraceptive. Clin Drug Investig. 2020 Aug;40(8):737-746. doi: 10.1007/s40261-020-00931-5.
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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
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 BIIB074 and OC (ethinyl estradiol and levonorgestrel) in people with Drug Interactions, 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 3 inclusion and 6 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 25 Sep 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. 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?
Area Under the Concentration-Time Curve from Hour 0 to Hour 8 (AUC8) for BIIB074 (time frame: Day 7, 32). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03324685, which also lists 1 linked publication.
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 25 Sep 2018.