Phase 1 Study to Evaluate the PK, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Healthy Volunteers (109HV108)

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BG00012 Dose 1; Drug: BG00012 Dose 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01453426

109HV108

Details and patient eligibility

About

This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and Caucasian healthy volunteers.

Full description

The purpose of this healthy volunteer study is to provide pharmacokinetic and safety data for two different dose regimens of BG00012. The study will evaluate BG00012 administered over a 24-hour period.

The study will be conducted in male and female Chinese, Japanese, and Caucasian healthy volunteers.

Enrollment: 71 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must give written informed consent and any authorizations required by local law
• All subjects must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Exclusion criteria

• History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
• History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible)
• History of severe allergic or anaphylactic reactions
• Known history of or positive test result for Human Immunodeficiency Virus (HIV)
• Serious infection (e.g., pneumonia, septicemia) within 2 months prior to Screening.
• Female subjects who are pregnant or currently breastfeeding

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

71 participants in 6 patient groups

Chinese Subjects - Dose 1 BG00012

Experimental group

Treatment:

Drug: BG00012 Dose 1

Chinese Subjects - Dose 2 BG00012

Experimental group

Treatment:

Drug: BG00012 Dose 2

Japanese Subjects - Dose 1 BG00012

Experimental group

Treatment:

Drug: BG00012 Dose 1

Japanese Subjects - Dose 2 BG00012

Experimental group

Treatment:

Drug: BG00012 Dose 2

Caucasian Subjects - Dose 1 BG00012

Experimental group

Treatment:

Drug: BG00012 Dose 1

Caucasian Subjects - Dose 2 BG00012

Experimental group

Treatment:

Drug: BG00012 Dose 2