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-AST2818

Phase 1

Healthy Male Volunteers | Small molecule | Other |ArriVent BioPharma, Inc.|Last Updated: Jan 6, 2020

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
RandomizedCONTROLLEDBiomarker
Total Trials2
Total Enrollment22
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03941340Study Evaluating the Mass Balance And Biotransformation of Single Dose[14C] AST2818 in Chinese Healthy Male VolunteersPHASE1 COMPLETED 6 — — Apr 8, 2019Sep 6, 2019Jan 6, 20201 China
NCT03926182Study to Determine the Effect of Food on the Blood Levels of AST2818 Following Single Oral Doses in Healthy Male VolunteersPHASE1 COMPLETED 16 — — Feb 19, 2019Apr 3, 2019Jan 6, 20201 China
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Study Endpoints
Primary Endpoints
The distribution of AST2818 in the whole blood and plasma and whole radioactive pharmacokinetics following the single orally administered [14C]-AST2818 in healthy male volunteers.
Blood samples (hrs) - 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, every 24 to 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 1848 and 2016.

The percentage of radioactive dose of \[14C\] radiolabelled AST2818 recovered in blood and in total, up to Day 85（p.s:The administration time on the first day is 7:30 am）

Quantitive analysis of whole radioactivity of excrement of orally administered [14C]-AST2818 in healthy volunteers to obtain the mass balance data and the main excretion pathway in human body.
Urine and faeces (hrs): 0-4, 4-8, 8-12, 12-24, every 24 to 504, 624-672, 792-840, 960-1008, 1128-1176, 1296-1344, 1464-1512, 1632-1680, 1800-1848 and 1968-2016.

The percentage of radioactive dose of \[14C\] radiolabelled AST2818 recovered in urine, faeces and in total, up to Day 85（p.s:The administration time on the first day is 7:30 am）

Quantitive analysis of the concentrations of AST2818 and AST5902 (Metabolite of AST2818) in plasma using the validated LC-MS/MS to obtain pharmacokinetic data;
Blood samples (hrs) - 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, every 24 to 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 1848 and 2016.

The concentrations of AST2818 and AST5902 in plasma up to Day 85（p.s:The administration time on the first day is 7:30 am）

Proportion of different metabolites in healthy volunteers after oral administration of [14C]-AST2818
Blood samples (hrs) - 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, every 24 to 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 1848 and 2016.

Proportion of different metabolites

Types of adverse events assessed by CTCAE v5.0 that occurred during the trial
Baseline (Day-1) to Day 85（p.s:The administration time on the first day is 7:30 am）

Types of adverse events

Cmax of AST2818
Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups.

Pharmacokinetics of AST2818 by assessment of maximum plasma AST2818 concentration.

AUC(0-t) of AST2818
Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups.

Pharmacokinetics of AST2818 by assessment of area under the plasma concentration time curve from zero to appointed time

Tmax of AST2818
Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups.

Pharmacokinetics of AST2818 by assessment of time to Cmax.

Secondary Endpoints
Cmax of AST5902
Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups.
AUC(0-t) of AST5902
Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups.
Tmax of AST5902
Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
[14C]-AST2818 80mg (oral solution)EXPERIMENTALVolunteers will receive 80 mg \[14C\]-AST2818 containing a nominal 100 μCi activity, administered by mouth, as a solution.
Fasted AST2818 tablets following a period of fastingEXPERIMENTAL -
High-fat meal AST2818 tablets following a high-fat mealEXPERIMENTAL -
Interventions
NameTypeDescription
[14]-AST2818DRUGVolunteer will receive a single oral dose of 80 mg /100 u Ci \[14C\]-AST2818 as a solution on Day 1
AST2818 TabletsDRUGAST2818 Tablets: Period 1 Fasted from 10 hours prior to dosing with 80 mg AST2818 tablet (p o, once) and 4 hours after dosing on day 1. Period 2 Allocated high-fat meal prior to dosing with 80 mg AST2818 tablet (p o, once) and fasted 4 hours after dosing on day 1.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy adult; 2. Body weight: The body mass index varies in the range of 19 - 26 kg/m2 (including 19 and 26 kg/m2); 3. Signing the informed consent forms by oneself ; 4. Be able to communicate well with the researcher and be able to complete the trial in accordance with the ...

Countries:China
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