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First Test Concor

Phase 1

Undisclosed | Small molecule | Other |Merck KGaA|Trials Updated: Aug 2, 2023

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

First Test Concor clinical trials

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 First Test Concor?

First Test Concor is an investigational small molecule developed by Merck KGaA. It has been studied in a Phase 1 bioequivalence trial in healthy adult participants in China. The specific therapeutic indication for First Test Concor has not been disclosed.

Who makes First Test Concor?

First Test Concor is developed by Merck KGaA, which trades under the ticker MKGAF. The company sponsored the clinical trial evaluating the drug candidate.

What phase is First Test Concor in?

First Test Concor is in Phase 1 clinical development. It is investigational and has been evaluated in one completed Phase 1 trial. There are currently no active trials of First Test Concor listed.

What clinical trials is First Test Concor in?

First Test Concor has been studied in one completed Phase 1 trial, NCT05930808, titled Concor Bioequivalence Study in Chinese Participants (Darmstadt-Nantong). The trial enrolled 46 healthy adult volunteers in China, was randomized and controlled, and included both male and female participants aged 18 years and older.

Is First Test Concor the same as First Test Concor (Fasted)?

Yes, First Test Concor (Fasted) is another name for First Test Concor. Both names refer to the same investigational drug candidate developed by Merck KGaA.