A Phase 1 interventional study of BIIB074 and OC (ethinyl estradiol and levonorgestrel) in Drug Interactions, sponsored by Biogen. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-25.
Sponsored by Biogen · Phase 1, Interventional, and Treatment
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE:Other protocol defined Inclusion/Exclusion criteria may apply
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)
BIIB074 is administered as specified in the treatment arm.
OC is administered as specified in the treatment arm.
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
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
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
12-lead ECGs measurements are heart rate, PR interval, RR interval, QRS duration, QT interval, and QTcF
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Day 7, 12, 24, 33, and once between Day 39-42
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