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AZD4144 for Infusion

Phase 1

Healthy Participants | Small molecule | Other |AstraZeneca PLC|Last Updated: Apr 8, 2026

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07518459A Study of Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]AZD4144PHASE1 ACTIVE NOT_RECRUITING 8Feb 11, 2026May 28, 2026Apr 8, 20261 United Kingdom
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Study Endpoints
Primary Endpoints
Amount of AZD4144 excreted (Ae)
Urine and faecal samples collected from pre-dose until up to 216 hours post-dose

Mass balance recovery, rates and routes of elimination of total radioactivity of \[14C\]AZD4144 in urine, faecal and all excreta

Amount of AZD4144 excreted expressed as a percentage of the radioactive dose administered (Fe)
Urine and faecal samples collected from pre-dose until up to 216 hours post-dose

Mass balance recovery, rates and routes of elimination of total radioactivity of \[14C\]AZD4144 in urine, faeces and all excreta

Cumulative amount of AZD4144 excreted (CumAe)
Urine and faecal samples collected from pre-dose until up to 216 hours post-dose

Mass balance recovery, rates and routes of elimination of total radioactivity of \[14C\]AZD4144 in urine, faecal and all excreta

Cumulative amount of AZD4144 excreted expressed as a percentage of the radioactive dose administered (CumFe)
Urine and faecal samples collected from pre-dose until up to 216 hours post-dose

Mass balance recovery, rates and routes of elimination of total radioactivity of \[14C\]AZD4144 in urine, faecal and all excreta

Area under the curve (AUC) of circulating plasma total radioactivity (TR) accounting for 10% or more of the dose
Plasma, urine and faecal samples from pre-dose until up to 216 hours post-dose

Identification of the chemical structure of each metabolite accounting for more than 10% by AUC of circulating total radioactivity

80% or more of the radioactivity recovered in excreta
Plasma, urine and faecal samples from pre-dose until up to 216 hours post-dose

Identification of greater than 80% of the radioactivity recovered in the urine and/or faeces

Secondary Endpoints
Time of maximum observed concentration (tmax) for AZD4144 and total radioactivity
Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Maximum observed concentration (Cmax) for AZD4144 and total radioactivity
Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Area under the curve from time 0 to the time of last measurable concentration (AUC0-t) for AZD4144 and total radioactivity
Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Regimen AEXPERIMENTALParticipants in Cohort 1 will receive a single intravenous injection of \[14C\]AZD4144 Solution for Infusion
Regimen BEXPERIMENTALParticipants in Cohort 2 will receive a single oral dose of \[14C\]AZD4144 Oral Solution
Interventions
NameTypeDescription
[14C]AZD4144 Solution for InfusionDRUGIntravenous, fasted
[14C]AZD4144 Oral SolutionDRUGOral, fasted
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Eligibility Criteria
Age Range30 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males aged 30 to 65 years inclusive * BMI of 18.0 to 32.0 kg/m2 inclusive * Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day) Exclusion Criteria: * History of any clinically important disease or disorder * History or presence of clin...

Countries:United Kingdom
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