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

• Sponsor: Biogen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01453426
• Collaborator: (none)
• Enrollment: 71
• Locations: 2
• Arms: 6
• Duration (Months): 3
• Patients Per Site: 35.5
• Patients Per Site Per Month: 11.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BG00012 Dose 1; Drug: BG00012 Dose 2	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: An Open-Label, Parallel-Group, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chinese Subjects - Dose 1 BG00012	Drug: BG00012 Dose 1
Experimental: Chinese Subjects - Dose 2 BG00012	Drug: BG00012 Dose 2
Experimental: Japanese Subjects - Dose 1 BG00012	Drug: BG00012 Dose 1
Experimental: Japanese Subjects - Dose 2 BG00012	Drug: BG00012 Dose 2
Experimental: Caucasian Subjects - Dose 1 BG00012	Drug: BG00012 Dose 1
Experimental: Caucasian Subjects - Dose 2 BG00012	Drug: BG00012 Dose 2

Outcome Measures

Primary Outcome Measures

1. AUC of BG00012 [First dose to 24 hours]

2. Cmax of BG00012 [First dose to 24 hours]

Secondary Outcome Measures

1. Number of Adverse Events, as a measure of safety and tolerability [Subjects will be followed for the duration of the study, an expected 20 days]

2. Number of Serious Adverse Events, as a measure of safety and tolerability [Subjects will be followed for the duration of the study, an expected 20 days]

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Melbourne	Victoria	Australia
2	Research Site	Hong Kong	Hong Kong	China

Sponsors and Collaborators

• Biogen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT01453426
• Other Study ID Numbers: 109HV108
• First Posted: Oct 17, 2011
• Last Update Posted: Sep 16, 2013
• Last Verified: May 1, 2012

• Additional relevant MeSH terms: Dimethyl Fumarate

Study Results

No Results Posted as of Sep 16, 2013