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-PC14586

Phase 1

Healthy Male Volunteers | Small molecule | Other |PMV Pharmaceuticals, Inc.|Last Updated: Dec 20, 2022

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 Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05523687AME Study of [14C]-PC14586 in Healthy Male ParticipantsPHASE1 COMPLETED 8 — — Sep 6, 2022Nov 30, 2022Dec 20, 20221 United States
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Study Endpoints
Primary Endpoints
Characterize Maximum Plasma Concentration (Cmax) of PC14586 and PC14586 metabolite M1 (PC16163).
1 month

Determine Cmax for PC14586 and PC16163 in plasma.

Characterize Time to Maximum Plasma Concentration (tmax) of PC14586 and PC14586 metabolite M1 (PC16163).
1 month

Determine tmax for PC14586 and PC16163 in plasma.

Characterize Total Drug Exposure (AUC0-inf) of PC14586 and PC14586 metabolite M1 (PC16163).
1 month

Determine AUC0-inf for PC14586 and PC16163 in plasma.

Characterize Total Drug Exposure to the last measurable concentration (AUC0-t) of PC14586 and PC14586 metabolite M1 (PC16163).
1 month

Determine AUC0-t for PC14586 and PC16163 in plasma.

Characterize the Half-Life (t 1/2) of PC14586 and PC14586 metabolite M1 (PC16163).
1 month

Determine t 1/2 for PC14586 and PC16163 in plasma.

Characterize the Clearance (CL/F) of PC14586 and PC14586 metabolite M1 (PC16163) after oral administration.
1 month

Determine CL/F for PC14586 and PC16163 in plasma.

Characterize the Volume of Distribution (Vd/F) of PC14586 and PC14586 metabolite M1 (PC16163) after oral administration.
1 month

Determine Vd/F for PC14586 and PC16163 in plasma.

Determine the total radioactivity in whole blood and plasma of PC14586 and PC14586 metabolite M1 (PC16163).
1 month

Determine total radioactivity for PC14586 and PC16163 in whole blood and plasma.

Characterize total radioactivity (Xlast, feces) of PC14586 excreted in feces.
1 month

Determine total radioactivity of PC14586 excreted in feces

Characterize the half life of total radioactivity (Xt1-t2, feces) of PC14586 excreted in feces.
1 month

Determine half life of total radioactivity of PC14586 excreted in feces.

Characterize the fraction excreted of total radioactivity (fe last, feces) of PC14586 in feces.
1 month

Determine the fraction excreted of total radioactivity of PC14586 in feces.

Characterize the half-life of fraction excreted of total radioactivity (fe t1-t2, feces) of PC14586 in feces.
1 month

Determine half-life of fraction excreted of total radioactivity of PC14586 in feces.

Characterize total radioactivity (Xlast, urine) of PC14586 excreted in urine.
1 month

Determine total radioactivity of PC14586 excreted in urine.

Characterize the half life of total radioactivity (Xt1-t2, urine) of PC14586 excreted in urine.
1 month

Determine half life of total radioactivity of PC14586 excreted in urine.

Characterize the fraction excreted of total radioactivity (fe last, urine) of PC14586 in urine.
1 month

Determine the fraction excreted of total radioactivity of PC14586 in urine.

Characterize the half-life of fraction excreted of total radioactivity (fe t1-t2, urine) of PC14586 in urine.
1 month

Determine half-life of fraction excreted of total radioactivity of PC14586 in urine.

Characterize the renal clearance (CLr) of PC14586 in urine.
1 month

Determine the renal clearance of PC14586 in urine.

Secondary Endpoints
Identification of PC14586 metabolite profiles in plasma, urine and feces.
1 month
Identification of the incidence and severity of adverse events after administration of PC14586.
1 month
Identification of the incidence of laboratory abnormalities based on hematology, clinical chemistry and urine test results of PC14586.
1 month
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
Single, oral dose of [14C]-PC14586EXPERIMENTALHealthy, male participants will receive a single, oral dose of \[14C\]-PC14586
Interventions
NameTypeDescription
[14C]-PC14586DRUGSingle, oral dose of \[14C\]-PC14586
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy, non-smoking males of any race, between 18 and 55 years of age, with BMI between 18.0 and 32.0 kg/m2 inclusive. 2. In good health, determined by no clinically significant findings from medical history and evaluations at screening and check-in as assessed by the invest...

Countries:United States
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