Recent Updates
Recently added Catalysts

Experimental

Phase 1

Healthy Volunteers | Small molecule | Other |Biogen Inc.|Last Updated: Nov 4, 2011

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Experimental · 1 trial · 1 indication

Phase 1 1
NCT01420458Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012Healthy Volunteers
COMPLETED80 Analytics
PHASE1COMPLETED
Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012
Healthy Volunteers
NCT0142045880
Unlock trial analytics

Study Endpoints

Primary Endpoints

Area under the plasma concentration curve as a measure of PK.
Participants will be followed during the duration of the study, 4 days. Samples taken at -15mins, 30 mins, 60 mins, 90 mins, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 7 hrs, 8 hrs, 10 hrs, 12 hrs

Secondary Endpoints

The number of AEs in participants as a measure of safety and tolerability.
Participants will be followed during the time of study - an estimated four days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Interventions

NameTypeDescription
ExperimentalDRUGBioequivalence of two drug formulations
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Must give written and informed consent and any authorizations required by local law. * Males and females 18 - 55 years old inclusive at time of consent. * Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive Exclusion Criteria: * History of malignancy (...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Experimental

What is Experimental used for?

Experimental is an investigational small molecule being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial to establish the bioequivalence of two formulations of BG00012. The drug is not approved and remains in clinical development.

Who makes Experimental?

Experimental is being developed by Biogen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical research on this investigational small molecule in healthy volunteer studies.

What phase is Experimental in?

Experimental is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a bioequivalence study in healthy volunteers. The drug is investigational and has not been approved for any use.

What clinical trials is Experimental in?

Experimental has been studied in one clinical trial, identified as NCT01420458. This Phase 1 study, titled "Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012," was completed in the United States with 80 participants.

Is Experimental the same as BG00012?

Yes, Experimental is being studied as BG00012 in clinical trials. The completed Phase 1 trial, NCT01420458, evaluated the bioequivalence of two formulations of BG00012 in healthy volunteers. This was an uncontrolled, non-randomized study.