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AF-130

Phase 1

Healthy Volunteers | Small molecule | Other |Merck & Company, Inc.|Last Updated: Dec 6, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

AF-130 · 1 trial · 1 indication

Phase 1 1
NCT02652936A Pharmacokinetics Study of AF-130 in Healthy SubjectsHealthy Volunteers
COMPLETED80 Analytics
PHASE1COMPLETED
A Pharmacokinetics Study of AF-130 in Healthy Subjects
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Study Endpoints

Primary Endpoints

Number of subjects with treatment-related adverse events following a single oral dose of AF-130
48 hours
Number of subjects with treatment-related adverse events following multiple oral doses of AF-130
7 days

Secondary Endpoints

Maximum plasma concentration (Cmax) profile of an oral formulation of AF-130
48 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AF-130 capsuleEXPERIMENTALAF-130 oral capsules administered as a single dose or once daily for 7 days
AF-130 matching placebo capsulePLACEBO_COMPARATOROral placebo capsules to match AF-130 administered as a single dose or once daily for 7 days

Interventions

NameTypeDescription
AF-130DRUGAF-130 oral capsules (50 mg) administered as a single dose or once daily for 7 days
Placebo comparatorDRUGAF-130 matching placebo capsule
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males * Age 18 to 55 years * Body mass index of 18.0 to 35.0 kg/m2 * Willing and able to communicate and participate in the whole study * Must provide written informed consent * Must agree to use an adequate method of contraception Exclusion Criteria: * Participation...

Countries:United Kingdom
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Frequently asked questions about AF-130

What is AF-130 used for?

AF-130 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is currently in clinical development for research purposes only.

Who makes AF-130?

AF-130 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK on the New York Stock Exchange.

What phase is AF-130 in?

AF-130 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is AF-130 in?

AF-130 has one completed Phase 1 trial, NCT02652936, a pharmacokinetics study in healthy subjects. The trial enrolled 80 male participants in the United Kingdom and was placebo-controlled and double-blind.

Is AF-130 the same as any other drug?

No alternative names for AF-130 have been reported. It is identified solely by the code name AF-130 in clinical trial records.