Recent Updates
Recently added Catalysts

Megestrol

Phase 1

Pharmacokinetics | Small molecule | Gastrointestinal |BrainsWay Ltd.|Last Updated: Apr 19, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Megestrol · 1 trial · 3 indications

Phase 1 1
NCT00638079Evaluating the Effect of Food on Absorption of Megace ESPharmacokinetics
COMPLETED24 Analytics
PHASE1COMPLETED
Evaluating the Effect of Food on Absorption of Megace ES
PharmacokineticsUnlock trial analytics

Study Endpoints

Primary Endpoints

Rate and extent of absorption
120 hours (5 days)
Safety assessed using adverse events (AEs), clinical laboratory results, vital signs, physical examinations, and ECGs.
signing of informed consent to 30 days after last study visit
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
AEXPERIMENTALMegestrol acetate 625 mg/5 mL oral suspension (Megace ES) with a high fat meal
BACTIVE_COMPARATORMegestrol acetate 625 mg/5 mL oral suspension (Megace ES) following an overnight fast

Interventions

NameTypeDescription
Megestrol acetate oral suspension 625 mg/5 mLDRUGMegestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered with a high fat meal
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body weight ranging from 60-100 kg (132-220 lbs) and body mass index ≥18 and ≤32 * Healthy Exclusion Criteria: * History of or any current medical conditions that could interfere with drug consumption, absorption, distribution, metabolism (eg. CYP450 inducers or inhibitors),...

Countries:Canada
Unlock Eligibility Criteria

Frequently asked questions about Megestrol

What is Megestrol used for?

Megestrol is a small molecule being studied for pharmacokinetics, specifically to evaluate the effect of food on its absorption. It is in Phase 1 clinical development for this purpose. The drug is being developed by BrainsWay Ltd. and is in the gastrointestinal therapeutic area.

What does Megestrol target?

Megestrol does not have a specified molecular target or target class. It is a small molecule being studied for its pharmacokinetic properties, particularly how food affects its absorption. The drug is in Phase 1 clinical development.

Who makes Megestrol?

Megestrol is being developed by BrainsWay Ltd., a company traded under the ticker BWAY. The drug is in Phase 1 clinical development for pharmacokinetic studies. BrainsWay Ltd. is conducting research on this small molecule in the gastrointestinal therapeutic area.

What phase is Megestrol in?

Megestrol is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied for pharmacokinetics. The drug has completed one Phase 1 trial, which evaluated the effect of food on its absorption.

What clinical trials is Megestrol in?

Megestrol has one completed clinical trial, NCT00638079, titled 'Evaluating the Effect of Food on Absorption of Megace ES'. This Phase 1 study enrolled 24 healthy male volunteers in Canada and was active-controlled. The trial focused on pharmacokinetics, bioavailability, and absorption.

Is Megestrol the same as Megace ES?

Megestrol is the drug being studied, and the clinical trial NCT00638079 evaluates 'Megace ES', which is a formulation of megestrol. The trial assesses the effect of food on the absorption of this formulation. Megestrol is in Phase 1 development for pharmacokinetics.