Recent Updates
Recently added Catalysts

Colesevelam film-coated

Phase 1

Undisclosed | Small molecule | Other |Sanofi|Trials Updated: May 5, 2015

Colesevelam film-coated target and mechanism

ModalitySmall molecule

Also known as Colesevelam hydrochloride film-coated tablets (Cholestagel)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Colesevelam film-coated clinical trials

Colesevelam film-coated · 1 trial · 1 indication

Phase 1 1
NCT00692250A Study to Assess Any Potential Interaction Between Colesevelam and Ciclosporin in Healthy VolunteersHealthy
COMPLETED14 Analytics
PHASE1COMPLETED
A Study to Assess Any Potential Interaction Between Colesevelam and Ciclosporin in Healthy Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioavailability of Ciclosporin (AUC(0-t), AUC(∞) and C(max))
12 weeks

Secondary Endpoints

Safety
12
Tolerability
12 Weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL

Interventions

NameTypeDescription
Colesevelam hydrochloride film-coated tablets (Cholestagel)DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subject must have a body mass index (BMI) between 19 and 25 inclusive * Medically healthy subjects with clinically normal laboratory profiles, physical exams, vital signs and ECGs. * Give voluntary written informed consent to participate in the study Exclusion Criteria: * Hi...

Countries:Netherlands
Unlock Eligibility Criteria

Frequently asked questions about Colesevelam film-coated

What is Colesevelam film-coated?

Colesevelam film-coated is a film-coated tablet formulation of colesevelam hydrochloride, also known as Cholestagel. It is a small molecule developed by Sanofi (ticker SNY). The specific indication for this film-coated presentation is undisclosed, and it has been studied in a Phase 1 trial in healthy volunteers.

Who makes Colesevelam film-coated?

Colesevelam film-coated is made by Sanofi, which trades under the ticker SNY. Sanofi is the developer of the colesevelam hydrochloride film-coated tablets also known as Cholestagel.

What phase is Colesevelam film-coated in?

Colesevelam film-coated is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. It is an investigational formulation and is not approved for any indication based on the available development data.

What clinical trials is Colesevelam film-coated in?

Colesevelam film-coated has been evaluated in one completed Phase 1 trial, NCT00692250, titled A Study to Assess Any Potential Interaction Between Colesevelam and Ciclosporin in Healthy Volunteers. The trial enrolled 14 healthy male volunteers in the Netherlands and was randomized but uncontrolled.

Is Colesevelam film-coated the same as Cholestagel?

Yes, Colesevelam film-coated is also known as colesevelam hydrochloride film-coated tablets (Cholestagel). Cholestagel is the brand name for this film-coated formulation developed by Sanofi.