A Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Randomized, Open-Label, Parallel-Arm Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05152485
• Other study ID #: 263HV109
• Status: Completed
• Phase: Phase 1
• Start date: December 15, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2023
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study are to evaluate the relative bioavailability of the BIIB104 test formulation compared with the reference formulation in healthy Caucasian male adult participants in the fasted state and to assess the impact of food on BIIB104 pharmacokinetic (PK) parameters for the test formulation in healthy Caucasian male adult participants.

The secondary objective of the study is to assess the safety and tolerability of BIIB104 0.5 milligrams (mg) test formulation in the fasted and fed states following single-dose administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Key Inclusion Criteria:

• Has a body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2), inclusive and a total body weight >50 kilograms [110 pound (lb)].

Key Exclusion Criteria:

• Participates in other studies involving treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to randomization and/or during study participation.

• Previously participated in this study or previous studies with BIIB104.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BIIB104 Reference Formulation
Administered as specified in the treatment arm
• BIIB104 Test Formulation
Administered as specified in the treatment arm

Locations

Country	Name	City	State
United States	QPS MRA	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration-Time Curve from Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB104		Up to Day 6
Primary	Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUCinf) of BIIB104		Up to Day 6
Primary	Maximum Observed Plasma Concentration (Cmax) of BIIB104		Up to Day 6
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax) for BIIB104		Up to Day 6
Secondary	Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	An 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 AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs that start or worsen after receiving the study drug. An SAE is any untoward medical occurrence that at any dose results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); 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.	From Day 1 up to end of study (up to Day 16)
Secondary	Number of Participants with Clinically Significant Abnormalities in Clinical Laboratory Parameters		From Day 1 up to end of study (up to Day 16)
Secondary	Number of Participants with Clinically Significant Abnormalities in Vital Signs		From Day 1 up to end of study (up to Day 16)
Secondary	Number of Participants with Clinically Significant Abnormalities in Physical Examination Parameters		From Day 1 up to end of study (up to Day 16)