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Completed

NCT Number: NCT03324685

A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen

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.

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Key information

Conditions

Drug Interactions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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:

  • 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

Treatment and study plan

BIIB074

Drug

BIIB074 is administered as specified in the treatment arm.

OC (ethinyl estradiol and levonorgestrel)

Drug

OC is administered as specified in the treatment arm.

Primary outcomes

  1. Area Under the Concentration-Time Curve from Hour 0 to Hour 8 (AUC8) for BIIB074

    Time frame: Day 7, 32

  2. Area Under the Concentration-Time Curve from Hour 0 to Hour 24 (AUC24) for OC

    Time frame: Day 25, 32

  3. Maximum Observed Concentration (Cmax) for BIIB074

    Time frame: Day 7, 32

  4. Maximum Observed Concentration (Cmax) for OC

    Time frame: Day 25, 32

  5. Time to Reach Maximum Observed Concentration (Tmax) for BIIB074

    Time frame: Day 7, 32

  6. Terminal Elimination Half-Life (t1/2) of BIIB074

    Time frame: Day 7, 32

  7. Apparent Clearance (CL/F) for BIIB074

    Time frame: Day 7, 32

  8. Apparent Volume of Distribution at Steady State (Vss/F) for BIIB074

    Time frame: Day 7, 32

  9. Time to Maximum Observed Concentration (Tmax) for OC

    Time frame: Day 25, 32

  10. Terminal Elimination Half-Life (t1/2) of OC

    Time frame: Day 25, 32

  11. Apparent Clearance (CL/F) for OC

    Time frame: Day 25, 32

  12. Apparent Volume of Distribution at Steady State (Vss/F) for OC

    Time frame: Day 25, 32

Secondary outcomes

  1. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Approximately 71 days

    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.

  2. Number of Participants with Abnormal Change from Baseline in Laboratory Parameters up to Day 33

    Time frame: Day 3, 7, 24, 28, 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.

  3. Number of Participants with Abnormal Change from Baseline in Hematology Panel up to Day 33

    Time frame: Day 3, 7, 24, 28, 33

    Hematology Panel measurements are complete blood count with differential and platelet count, and absolute neutrophil count

  4. Number of Participants with Abnormal Change from Baseline in Urinalysis Panel up to Day 33

    Time frame: Day 3, 7, 24, 28, 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.

  5. 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

    Vital signs measurements are temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate

  6. 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

    12-lead ECGs measurements are heart rate, PR interval, RR interval, QRS duration, QT interval, and QTcF

  7. Number of Participants with Abnormal Change from Baseline in Physical Examination up to Day 33

    Time frame: Day -1, 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.

  8. AUC 8 of BIIB074 Metabolites M13, M14, and M16

    Time frame: Day 7, 32

    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.

  9. Cmax for BIIB074 Metabolites M13, M14, and M16

    Time frame: Day 7, 32

    Cmax is the maximum serum concentration that BIIB074 metabolites M13, 14, and 16 achieves in the body after BIIB074 is administered.

  10. Tmax for BIIB074 Metabolites M13, M14, and M16

    Time frame: Day 7, 32

    Tmax is the amount of time it takes to reach Cmax of the BIIB074 metabolites13,14, and 16 after BIIB074 has been administered.

  11. Terminal Elimination Half-Life (T 1/2) for BIIB074 Metabolites M13, M14, and M16

    Time frame: Day 7, 32

    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.

  12. Metabolite-to-Parent Ratio in AUC (MRauc) for BIIB074 Metabolites M13, M14, and M16

    Time frame: Day 7, 32

    The MRauc is the ratio of the BIIB074 metabolites M13,14,and 16 to BIIB074 after administration

  13. 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

    The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the Pharmacokinetic Interaction Potential Between BIIB074 and an Oral Contraceptive Regimen in Healthy Female Subjects

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 30, 2017
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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