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KWA-0711

Phase 1

Healthy Male Subject | Small molecule | Other |Co-Diagnostics, Inc.|Last Updated: Apr 18, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02434835Study of Absorption, Metabolism and Excretion Following a Single Oral Dose of [14C]KWA-0711 to Healthy Male SubjectsPHASE1 COMPLETED - — — - -Apr 18, 20161 United Kingdom
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Study Endpoints
Primary Endpoints
Area under the plasma concentration-time curve (AUC) of total radioactivity, unchanged drug substance and its major metabolites
240 hours
Maximum observed plasma concentration (Cmax) of total radioactivity, unchanged drug substance and its major metabolites
240 hours
Cumulative radioactivity recovery in urine and feces
240 hours
Profiles of metabolites in plasma, urine and faeces
240 hours
Secondary Endpoints
Number of adverse events
240 hours
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Study Design & Arms
Treatment Arms
ArmTypeDescription
[14C]KWA-0711EXPERIMENTAL -
Interventions
NameTypeDescription
[14C]KWA-0711DRUG -
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Eligibility Criteria
Age Range35 Years — 55 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects who are male, caucasian, and between 35 and 55 years of age, inclusive. * Subjects who have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive. * Subjects who have a body weight between 50 and 100 kg, inclusive. * Subjects must have regular bowel movements...

Countries:United Kingdom
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