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

• Sponsor: Biogen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05152485
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 3
• Actual Duration (Months): 1.5
• Patients Per Site Per Month: 23.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: BIIB104 Reference Formulation; Drug: BIIB104 Test Formulation	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 15, 2021
• Actual Primary Completion Date: Jan 31, 2022
• Actual Study Completion Date: Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: BIIB104 0.5 mg Reference Formulation (Fasted State) Participants will receive BIIB104 0.5 mg, immediate-release liquid-filled hard-shell capsule, orally, on Day 1 in the fasted state.	Drug: BIIB104 Reference Formulation; Administered as specified in the treatment arm
Experimental: BIIB104 0.5 mg Test Formulation (Fasted State) Participants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fasted state.	Drug: BIIB104 Test Formulation; Administered as specified in the treatment arm
Experimental: BIIB104 0.5 mg Test Formulation (Fed State) Participants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fed state.	Drug: BIIB104 Test Formulation; Administered as specified in the treatment arm

Outcome Measures

Primary Outcome Measures

1. Area Under the Plasma Concentration-Time Curve from Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB104 [Up to Day 6]

2. Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUCinf) of BIIB104 [Up to Day 6]

3. Maximum Observed Plasma Concentration (Cmax) of BIIB104 [Up to Day 6]

4. Time to Reach Maximum Observed Plasma Concentration (Tmax) for BIIB104 [Up to Day 6]

Secondary Outcome Measures

1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [From Day 1 up to end of study (up to Day 16)]

   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.

2. Number of Participants with Clinically Significant Abnormalities in Clinical Laboratory Parameters [From Day 1 up to end of study (up to Day 16)]

3. Number of Participants with Clinically Significant Abnormalities in Vital Signs [From Day 1 up to end of study (up to Day 16)]

4. Number of Participants with Clinically Significant Abnormalities in Physical Examination Parameters [From Day 1 up to end of study (up to Day 16)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	QPS MRA	Miami	Florida	United States	33143

Sponsors and Collaborators

• Biogen

Investigators

• Study Director: Medical Director, Biogen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT05152485
• Other Study ID Numbers: 263HV109
• First Posted: Dec 9, 2021
• Last Update Posted: Feb 22, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 22, 2022