ISRCTN48011192
Active, not recruiting
Phase 1
A Phase I, open-label, fixed-sequence, crossover study to investigate the effect of itraconazole (CYP3A inhibitor) and phenytoin (CYP3A inducer) on BIIB113 and the effect of BIIB113 on midazolam (CYP3A substrate) in healthy participants
Biogen (United Kingdom)0 sites70 target enrollmentJune 29, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Biogen (United Kingdom)
- Enrollment
- 70
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Body mass index (BMI) between 18 and 30 kilograms per square meter (kg/m^2\) inclusive
- •2\. Weight \=50 kg at Screening
- •3\. Negative severe acute respiratory syndrome\-related coronavirus 2 (SARS\-CoV\-2\) test result within 5 days of Day \-1 prior to randomisation
- •4\. Infertile males as defined by Clinical Trials Facilitation and Coordination Group (CTFG) guidelines:
- •4\.1\. Permanently sterile by bilateral orchidectomy
- •4\.2\. Vasectomised males defined as follows:
- •4\.2\.1\. Minimum of 12 weeks after successful vasectomy surgical procedure, and
- •4\.2\.2\. Documentation of confirmation of successful vasectomy by postvasectomy semen analysis – information collected at least 12 weeks after the surgery
- •5\. All females of childbearing potential must practice contraception
Exclusion Criteria
- •1\. Suicidal ideation, per the Investigator’s clinical judgement, with some intent to act within 6 months prior to the start of Screening, per the Investigator’s clinical judgement or based on the C\-SSRS, corresponding to a response of ‘Yes’ on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation on the C\-SSRS, or a history of suicidal behaviour within 1 year prior to the start of Screening. Participants reporting suicidal ideation with intent to act or suicidal behaviour prior to the Day 1 visit should be excluded.
- •2\. History of systemic hypersensitivity reaction to BIIB113, itraconazole (Part A),
- •phenytoin (Part B), midazolam (Part C), other related drugs, or the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study.
- •3\. Any vaccination within 10 days prior to Day \-1 or intention to be vaccinated within 10 days after the last dose of study treatment.
- •4\. Use of any hormonal oral contraceptives, systemically acting hormone\-releasing
- •contraceptive implants (excluding intrauterine devices), and hormone\-replacement medication.
- •5\. Use of any prescription medication, over\-the\-counter oral medication (excluding acetaminophen \[\= 2 g/day]) or dietary and herbal supplements that are not inducers or inhibitors of drug metabolising enzymes or drug transporters within 7 days prior to Day \-1, and an unwillingness or inability to refrain from this use during study participation, unless specifically permitted elsewhere within the protocol.
- •6\. Use of any prescription medication, over\-the\-counter oral medication, or dietary and herbal supplements (e.g., St. John’s wort) that are a known inducer or inhibitor of drug metabolising enzymes (including but not limited to CYP3A) or drug transporters within 28 days of Day \-1 and an unwillingness to refrain from use during study participation.
- •NOTE: Other protocol\-defined inclusion/exclusion criteria may apply.
Outcomes
Primary Outcomes
Not specified
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