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AF-130

Phase 1

Undisclosed | Small molecule | Other |Merck & Company, Inc.|Trials Updated: Dec 6, 2016

AF-130 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

AF-130 clinical trials

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?

AF-130 is an investigational small molecule developed by Merck & Company, Inc. (ticker MRK). It has been studied in a Phase 1 clinical trial in healthy male volunteers. Merck has not publicly disclosed the specific disease or condition AF-130 is intended to treat.

Who makes AF-130?

AF-130 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck sponsored the Phase 1 pharmacokinetics study of AF-130 conducted in the United Kingdom.

What phase is AF-130 in?

AF-130 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The study was a randomized, double-blind, placebo-controlled pharmacokinetics trial in healthy subjects.

What clinical trials is AF-130 in?

AF-130 has been evaluated in one completed Phase 1 trial, NCT02652936, titled A Pharmacokinetics Study of AF-130 in Healthy Subjects. The trial enrolled 80 healthy male volunteers aged 18 years and older in the United Kingdom and was randomized, double-blind, and placebo-controlled.

Is AF-130 FDA approved?

AF-130 is not approved. It is an investigational small molecule that has completed a single Phase 1 pharmacokinetics study in healthy volunteers. No Phase 2 or later-stage trials of AF-130 are listed, and its development status beyond Phase 1 has not been announced.