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First Test Concor

Phase 1

Healthy | Small molecule | Other |Merck KGaA|Last Updated: Aug 2, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

First Test Concor · 1 trial · 1 indication

Phase 1 1
NCT05930808Concor® Bioequivalence Study in Chinese Participants (Darmstadt-Nantong)Healthy
COMPLETED46 Analytics
PHASE1COMPLETED
Concor® Bioequivalence Study in Chinese Participants (Darmstadt-Nantong)
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetic (PK) Plasma Concentrations of Drug Concor under Fasted and Fed condition
Pre-dose up to 48 hours post-dose on Day 1 and Day 8

Secondary Endpoints

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Death, and AEs Leading to Discontinuation
Baseline up to Day 30 (approximately 4 weeks)
Number of Participants with Abnormal Vital Signs, Laboratory Variables, 12-Lead Electrocardiogram (ECG) and Physical Examination
Baseline up to Day 30 (approximately 4 weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
First Test Concor (Fasted), Then Reference Concor (Fasted)EXPERIMENTALParticipants will receive a single oral dose of Test Concor tablet on Day 1 in treatment period 1 followed by single oral dose of reference Concor tablet on Day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period.
First Reference Concor (Fasted), Then Test Concor (Fasted)EXPERIMENTALParticipants will receive a single oral dose of Reference Concor tablet on Day 1 in treatment period 1 followed by single oral dose of Test Concor tablet on day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period.
First Test Concor (Fed), Then Reference Concor (Fed)EXPERIMENTALParticipants will receive a single oral dose of Test Concor tablet on Day 1 in treatment period 1 followed by a single oral dose of Reference Concor tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period.
First Reference Concor (Fed), Then Test Concor (Fed)EXPERIMENTALParticipants will receive a single oral dose of Reference Concor tablet on Day 1 in treatment period 1 followed by a single oral dose of Test Concor tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period.

Interventions

NameTypeDescription
First Test Concor (Fasted)DRUGParticipants will receive single oral dose of Test Concor tablet under fasted or fed condition.
First Reference Concor (Fasted)DRUGParticipants will receive single oral dose of Reference Concor tablet under fasted or fed condition
First Test Concor (Fed)DRUGParticipants will receive single oral dose of Test Concor tablet under fasted or fed condition.
First Reference Concor (Fed)DRUGParticipants will receive single oral dose of Reference Concor tablet under fasted or fed condition.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests and cardiac monitoring * Participant must have a body weight within 50-90 kilogram (kg) and body mass index (BMI) within the range 19-26 kilo...

Countries:China
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Frequently asked questions about First Test Concor

What is Concor used for?

Concor is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed bioequivalence study in Chinese participants. The drug is being developed by Merck KGaA.

Who makes Concor?

Concor is being developed by Merck KGaA, a company traded under the ticker MKGAF. The drug is currently in Phase 1 clinical development, with one completed trial in healthy volunteers.

What phase is Concor in?

Concor is in Phase 1 clinical development. It has one completed trial, a bioequivalence study in healthy Chinese participants. The drug is investigational and has not been approved for any indication.

What clinical trials is Concor in?

Concor has one completed clinical trial, NCT05930808, a Phase 1 bioequivalence study in healthy Chinese participants. The study enrolled 46 participants and was conducted in China.

Is Concor the same as Concor?

Concor is the drug name used in clinical development. The completed trial, NCT05930808, is titled 'Concor® Bioequivalence Study in Chinese Participants (Darmstadt-Nantong).' No alternative names have been reported for this drug.