Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05127564 | Completed | Healthy Volunteers

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy Participants
Sponsor:

Biogen

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.

Condition or disease

Healthy Volunteers

Intervention/treatment

Diroximel fumarate

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 32 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official 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
Actual Study Start Date : December 3, 2021
Estimated Primary Completion Date : June 9, 2022
Estimated Study Completion Date : June 29, 2022
Arm Intervention/treatment

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.

Drug: Diroximel fumarate

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.

Drug: Diroximel fumarate
Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Key Inclusion Criteria
  • 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 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.
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy Participants

Location Details

Please Choose a site

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy Participants

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Hong Kong, New Territories

Research Site

Sha Tin, New Territories, Hong Kong, 8011

Not yet recruiting

New Zealand,

Research Site

Christchurch, New Zealand,