Research Site
Nottingham, United Kingdom
NCT Number: NCT04564612
The primary objectives of this study are: to evaluate the pharmacokinetic (PK) profiles of BIIB091 modified release (MR) formulations in healthy participants after single dose administration in the fasted state (Part 1); to evaluate the PK profile of the BIIB091 immediate release (IR) tablet formulation in healthy participants after single dose administration (Part 1B); to determine the relative bioavailability of single doses of the selected BIIB091 regimen in healthy participants taking a proton pump inhibitor (PPI) compared to healthy participants not taking a PPI, to determine the relative bioavailability of single doses of the selected BIIB091 regimen in healthy participants taking a cytochrome P450 (CYP)3A4 inhibitor compared to healthy participants not taking a CYP3A4 inhibitor (Part 2); to evaluate the PK of the selected BIIB091 regimen in healthy participants after multiple dose administration (Part 3).
The secondary objectives of this study are: to determine the relative bioavailability of a single dose of the BIIB091 MR formulations compared to that of the IR drug in capsule (DiC) reference formulation in healthy participants in the fasted state, to assess the safety and tolerability of single doses of BIIB091 when administered as MR formulations in healthy participants in the fasted state (Part 1); to determine the PK of a single dose of the BIIB091 IR tablet formulation in the fed and fasted state in healthy participants, to evaluate the PK profiles of the BIIB091 IR tablet formulation in healthy participants after administration of divided total daily doses over a 24 hour period in the fasted or fed state, to determine the relative bioavailability of a single dose or divided dose of the BIIB091 IR tablet formulation compared to that of the IR DiC reference formulation in healthy participants in the fasted state, to determine the PK of a single or divided dose of the BIIB091 IR tablet formulation administered with an alternative meal composition in healthy participants, to assess the safety and tolerability of a single or divided dose of BIIB091 when administered as the IR tablet formulation and IR DiC reference formulation in healthy participants in fed or fasted state (Part 1B); to confirm the PK profiles of the selected BIIB091 regimen in healthy participants after single dose administration, and to establish a reference exposure for the assessment of drug interaction, to assess the safety and tolerability of single doses of BIIB091 when administered as the selected BIIB091 regimen in healthy participants taking a PPI, to assess the safety and tolerability of single doses of BIIB091 when administered as the selected BIIB091 regimen in healthy participants taking a CYP3A4 inhibitor (Part 2); to assess the safety and tolerability of multiple doses of BIIB091 when administered as the selected BIIB091 regimen in healthy participants (Part 3).
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Nottingham, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Time frame: Part 1: Up to Day 4; Part 1B: Up to Day 5
Time frame: Part 1: Up to Day 4; Part 1B: Up to Day 5; Part 3: Up to Day 14
Time frame: Part 1: Up to Day 4; Part 1B: Up to Day 5; Part 3: Up to Day 14
Time frame: Parts 1 and 1B: 12 hours post-dose (Day 1)
Time frame: Parts 1 and 1B: 24 hours post-dose (Day 2)
Time frame: Parts 1 and 1B: Up to 12 hours post-dose (Day 1)
Time frame: Parts 1 and 1B: Up to 24 hours post-dose (Day 2)
Time frame: Part 1: Up to Day 4; Part 1B: Up to Day 5
Time frame: Part 1: Post-dose at multiple time points up to Day 4; Part 1B: Post-dose at multiple time points up to Day 5; Part 3: Post-dose at multiple time points up to Day 14
Time frame: Part 1: Up to Day 4; Part 1B: Up to Day 5
Time frame: Part 1: Up to Day 4; Part 1B: Up to Day 5; Part 3: Up to Day 14
Time frame: Part 1: Up to Day 4; Part 1B: Up to Day 5; Part 3: Up to Day 14
Time frame: Part 1: Up to Day 4; Part 1B: Up to Day 5
Time frame: Part 1: Up to Day 4; Part 1B: Up to Day 5
Time frame: Part 2: Up to Day 5
Time frame: Part 2: Up to Day 5
Time frame: Part 2: Up to Day 5
Time frame: Part 2: Up to Day 5
Time frame: Part 2: Up to Day 5
Time frame: Part 2: Up to Day 5
Time frame: Part 3: Up to Day 14
Time frame: Part 3: Up to Day 14
Time frame: Part 3: Up to Day 14
Time frame: Part 3: Up to Day 14
Time frame: Part 3: Up to Day 14
Time frame: Part 3: Up to Day 14
The formula used will be (Cmax-Cmin)/average concentration (Cavg) × 100.
Time frame: Part 3: Up to Day 14
Time frame: Part 3: Up to Day 14
Time frame: Part 3: Up to Day 14
Time frame: Part 3: Up to Day 14
Time frame: Part 1: Up to Day 4; Part 1B: Up to Day 5
Parameter will be evaluated for the fed versus (vs) fasted comparison and the alternative meal composition comparison.
Time frame: Part 1: Up to Day 4; Part 1B: Up to Day 5
Parameter will be evaluated for the fed vs fasted comparison and the alternative meal composition comparison.
Time frame: Part 1: Up to Day 4; Part 1B: Up to Day 5
Parameter will be evaluated for the fed vs fasted comparison and the alternative meal composition comparison.
Time frame: From Signing of Informed Consent Form (ICF) Until Follow-up Phone Call (Parts 1 and 1B: Up to 15 weeks; Part 2: Up to 10 weeks; Part 3: Up to 7 weeks)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event.
Time frame: Part 1: Up to Day 4; Parts 1B and 2: Up to Day 5; Part 3: Up to Day 14
Time frame: Parts 1B and 2: Up to Day 5
Parameter will be evaluated for the fed vs fasted comparison and the alternative meal composition comparison in Part 1B.
Time frame: Parts 1B and 2: Up to Day 5
Parameter will be evaluated for the fed vs fasted comparison and the alternative meal composition comparison in Part 1B.
Time frame: Parts 1B and 2: Up to Day 5
Parameter will be evaluated for the fed vs fasted comparison and the alternative meal composition comparison in Part 1B.
Time frame: Parts 1B and 2: 12 hours post-dose (Day 1)
Parameter will be evaluated for the fed vs fasted comparison and the alternative meal composition comparison in Part 1B.
Time frame: Parts 1B and 2: 24 hours post-dose (Day 2)
Parameter will be evaluated for the fed vs fasted comparison and the alternative meal composition comparison in Part 1B.
Time frame: Parts 1B and 2: Up to 12 hours post-dose (Day 1)
Parameter will be evaluated for the fed vs fasted comparison and the alternative meal composition comparison in Part 1B.
Time frame: Parts 1B and 2: Up to 24 hours post-dose (Day 2)
Parameter will be evaluated for the fed vs fasted comparison and the alternative meal composition comparison in Part 1B.
Time frame: Parts 1B and 2: Up to Day 5
Parameter will be evaluated for the fed vs fasted comparison and the alternative meal composition comparison in Part 1B.
Time frame: Parts 1B and 2: Post-dose at multiple time points up to Day 5
Parameter will be evaluated for the fed vs fasted comparison and the alternative meal composition comparison in Part 1B.
Time frame: Parts 1B and 2: Up to Day 5
Parameter will be evaluated for the fed vs fasted comparison and the alternative meal composition comparison in Part 1B.
Time frame: Parts 1B and 2: Up to Day 5
Parameter will be evaluated for the fed vs fasted comparison and the alternative meal composition comparison in Part 1B.
Time frame: Parts 1B and 2: Up to Day 5
Parameter will be evaluated for the fed vs fasted comparison and the alternative meal composition comparison in Part 1B.
Time frame: Parts 1B and 2: Up to Day 5
Parameter will be evaluated for the fed vs fasted comparison and the alternative meal composition comparison in Part 1B.
Time frame: Parts 1B and 2: Up to Day 5
Parameter will be evaluated for the fed vs fasted comparison and the alternative meal composition comparison in Part 1B.
Time frame: Part 1B: Up to Day 5
Biogen
Industry
An Open-Label, Pharmacokinetic Study to Evaluate the Pharmacokinetics and Relative Bioavailability of BIIB091 Formulations and to Assess the Impact of Food, a Proton Pump Inhibitor and CYP3A4 Inhibitor on BIIB091 Exposure Using the Selected Formulation in Healthy Subjects
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.
Published trials that share one or more normalized conditions with this study.
NCT05447078
Healthy Volunteers, Infections
Jackson, Mississippi, United States
View Trial DetailsNCT07513532
Healthy Volunteers
Seattle, Washington, United States
View Trial DetailsNCT07090655
Healthy Volunteers
Brisbane, Australia
View Trial DetailsNCT01915212
Communicable Diseases, DNA Virus Infections
Bethesda, Maryland, United States
View Trial Details