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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05127564




Registration number
NCT05127564
Ethics application status
Date submitted
9/11/2021
Date registered
19/11/2021
Date last updated
5/07/2022

Titles & IDs
Public title
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy Participants
Scientific title
An Open-Label, Parallel-Group, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (BIIB098) in Chinese and Caucasian Adult Healthy Participants
Secondary ID [1] 0 0
272HV111
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Diroximel fumarate

Experimental: DRF: Chinese Participants - Chinese participants will receive DRF Dose 1, oral capsules, twice daily (BID), from Day 1 to Day 4 and DRF Dose 1, oral capsules, once daily (QD), on Day 5.

Experimental: DRF: Caucasian Participants - Caucasian participants will receive DRF Dose 1, oral capsules, BID, from Day 1 to Day 4 and DRF Dose 1, oral capsules, QD, on Day 5.


Treatment: Drugs: Diroximel fumarate
Administered as specified in the treatment arm
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Observed Concentration (Cmax) of Monomethyl Fumarate (MMF)
Timepoint [1] 0 0
Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
Primary outcome [2] 0 0
Area Under the Concentration-Time Curve within a Dosing Interval (AUCtau) of MMF
Timepoint [2] 0 0
Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
Secondary outcome [1] 0 0
Time to Reach Maximum Observed Concentration (Tmax) of MMF
Timepoint [1] 0 0
Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
Secondary outcome [2] 0 0
Elimination Half-Life (t½) of MMF
Timepoint [2] 0 0
Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
Secondary outcome [3] 0 0
Lag Time in Absorption (Tlag) of MMF
Timepoint [3] 0 0
Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
Secondary outcome [4] 0 0
Apparent Total Body Clearance (CL/F) of MMF
Timepoint [4] 0 0
Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
Secondary outcome [5] 0 0
Apparent Volume of Distribution (Vz/F) of MMF
Timepoint [5] 0 0
Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
Secondary outcome [6] 0 0
Accumulation Ratio Following Multiple Dosing (Rac) of MMF
Timepoint [6] 0 0
Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
Secondary outcome [7] 0 0
Maximum Observed Concentration (Cmax) of 2-Hydroxyethyl Succinimide (HES)
Timepoint [7] 0 0
Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
Secondary outcome [8] 0 0
Area Under the Concentration-Time Curve within a Dosing Interval (AUCtau) of HES
Timepoint [8] 0 0
Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
Secondary outcome [9] 0 0
Time to Reach Maximum Observed Concentration (Tmax) of HES
Timepoint [9] 0 0
Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
Secondary outcome [10] 0 0
Elimination Half-Life (t½) of HES
Timepoint [10] 0 0
Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
Secondary outcome [11] 0 0
Lag Time in Absorption (Tlag) of HES
Timepoint [11] 0 0
Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
Secondary outcome [12] 0 0
Apparent Total Body Clearance (CL/F) of HES
Timepoint [12] 0 0
Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
Secondary outcome [13] 0 0
Apparent Volume of Distribution (Vz/F) of HES
Timepoint [13] 0 0
Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
Secondary outcome [14] 0 0
Accumulation Ratio Following Multiple Dosing (Rac) of HES
Timepoint [14] 0 0
Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
Secondary outcome [15] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [15] 0 0
Day 1 to Day 10
Secondary outcome [16] 0 0
Number of Participants with Serious Adverse Events (SAEs)
Timepoint [16] 0 0
Screening to Day 10

Eligibility
Key inclusion criteria
Key

- Have a body mass index (BMI) between 18 and 30 kilograms per meter square (kg/m^2),
inclusive.

- Negative polymerase chain reaction (PCR) test result for severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) at screening and Day -1.

- For Chinese participants: was born in China, and biological parents and grandparents
were of Chinese origin. If living outside China for more than 5 years, must not have
had a significantly modified diet since leaving China.

Key
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of severe allergic or anaphylactic reactions or of any allergic reactions
that, in the opinion of the investigator, are likely to be exacerbated by any
component of the study treatment; or systemic hypersensitivity reactions to DRF,
dimethyl fumarate (DMF), MMF, other fumaric esters, excipients in the formulation, or
diagnostic agents to be administered during the study.

- Confirmed demonstration of corrected QT interval, using Fridericia's correction
method, of >450 milliseconds (ms) for males and >460 ms for females.

- Has a history of gastrointestinal (GI) surgery (except appendectomy or cholecystectomy
that occurred more than 6 months prior to screening), irritable bowel syndrome,
inflammatory bowel disease (Crohn's disease, ulcerative colitis), or other clinically
significant and active GI condition, per the investigator's discretion.

- Has experienced clinically significant acute GI symptoms in the judgment of the
investigator within 30 days prior to admission.

- History or positive test result at screening for human immunodeficiency virus (HIV).

- Chronic, recurrent, or serious infection, as determined by the investigator, within 90
days prior to screening and between screening and Day -1.

- Current enrollment in any other drug, biological, device, or clinical study or
treatment with an investigational drug or approved therapy for investigational use
within 30 days prior to Day -1, or 5 half-lives, whichever is longer.

- Previous participation in this study or previous studies with DRF or DMF.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/06/2022
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
New Territories
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective is to evaluate the primary pharmacokinetic (PK) parameters of DRF
active metabolite monomethyl fumarate (MMF) following multiple doses of DRF in Chinese and
Caucasian adult healthy participants. The secondary objectives are to evaluate the secondary
PK parameters of DRF active metabolite MMF following multiple doses of DRF in Chinese and
Caucasian adult healthy participants, to evaluate the PK of DRF inactive major metabolite
2-hydroxyethyl succinimide (HES) following multiple doses of DRF in Chinese and Caucasian
adult healthy participants and to evaluate the safety and tolerability of multiple oral doses
of DRF in Chinese and Caucasian adult healthy participants.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05127564
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries