A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen

NCT03324685 | Completed Phase 1 FDA Drug

• 1 other identifier: 802HV108
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Oral Contraceptive, Healthy Volunteers, Ethinyl Estradiol,; Levonorgestrel

Outcome Measures

Primary Outcomes (12)

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

  Day 7, 32

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

  Day 25, 32

• Maximum Observed Concentration (Cmax) for BIIB074

  Day 7, 32

• Maximum Observed Concentration (Cmax) for OC

  Day 25, 32

• Time to Reach Maximum Observed Concentration (Tmax) for BIIB074

  Day 7, 32

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

  Day 7, 32

• Apparent Clearance (CL/F) for BIIB074

  Day 7, 32

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

  Day 7, 32

• Time to Maximum Observed Concentration (Tmax) for OC

  Day 25, 32

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

  Day 25, 32

• Apparent Clearance (CL/F) for OC

  Day 25, 32

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

  Day 25, 32

Secondary Outcomes (13)

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

  Approximately 71 days

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

  Day 3, 7, 24, 28, 33

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

  Day 3, 7, 24, 28, 33

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

  Day 3, 7, 24, 28, 33

• Number of Participants with Abnormal Change from Baseline in Vital Sign Measurements up to Day 33

  Day 1, 3, 7, 12, 24, 25, 26, 28, 33

Study Arms (1)

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.

Drug: BIIB074; Drug: OC (ethinyl estradiol and levonorgestrel)

Interventions

BIIB074 DRUG

BIIB074 is administered as specified in the treatment arm.

BIIB074 150 mg and Oral Contraceptive

OC (ethinyl estradiol and levonorgestrel) DRUG

OC is administered as specified in the treatment arm.

BIIB074 150 mg and Oral Contraceptive

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Daytona Beach, Florida, 32117, United States

Location

Related Publications (1)

• 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.

  PMID: 32564301 DERIVED

MeSH Terms

Interventions

vixotrigine; Ethinyl Estradiol; Levonorgestrel

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norgestrel; Norpregnenes

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 30, 2017
• Study Start: November 11, 2017
• Primary Completion: March 15, 2018
• Study Completion: March 15, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Locations

US (1)