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Danicopan Modified Release Prototype 1

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Aug 20, 2021

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 Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03384186A Study of Modified Release Formulations of Danicopan in Healthy Adult ParticipantsPHASE1 COMPLETED 14 — — Dec 1, 2017Mar 21, 2018Aug 20, 20211 United Kingdom
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Study Endpoints
Primary Endpoints
Time To Maximum Observed Concentration (Tmax) Of Danicopan After Treatment With Each Prototype Formulation
Up to 72 hours postdose
Maximum Observed Concentration (Cmax) Of Danicopan After Treatment With Each Prototype Formulation
Up to 72 hours postdose
Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Danicopan After Treatment With Each Prototype Formulation
Up to 72 hours postdose
Secondary Endpoints
Participants Experiencing Treatment-emergent Adverse Events
Day 1 (postdose) through follow-up visit (10 [+/- 2] days after last study drug administration)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Danicopan Modified Release Prototype TabletsEXPERIMENTALParticipants received danicopan once each period as a single oral dose as follows: Period 1: Danicopan Modified Release Prototype 1 under fasted conditions. Period 2: Danicopan Modified Release Prototype 2 under fasted conditions. Period 3: Danicopan Modified Release Prototype 3 under fasted conditions. Period 4: Danicopan Modified Release Prototype 2 under fed conditions. There was a washout period of at least 14 days between each danicopan dosing.
Interventions
NameTypeDescription
Danicopan Modified Release Prototype 1DRUGDanicopan (400 milligrams \[mg\]) oral tablet.
Danicopan Modified Release Prototype 2DRUGDanicopan (400 mg) oral tablet.
Danicopan Modified Release Prototype 3DRUGDanicopan (800 mg) oral tablet.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index of 18.0 to 30.0 kilograms/square meter. * Female participants of childbearing potential must either agree to abstinence or use of a highly effective method of contraception. * Male participants must either agree to abstinence or use of a condom plus an effectiv...

Countries:United Kingdom
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