A study to assess the effect of itraconazole and phenytoin on BIIB113 and the effect of BIIB113 on midazolam in healthy participants
- Conditions
- Healthy volunteersNot Applicable
- Registration Number
- ISRCTN48011192
- Lead Sponsor
- Biogen (United Kingdom)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 70
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method