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Danicopan Modified Release Prototype 1

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

Danicopan Modified Release Prototype 1 · 1 trial · 1 indication

Phase 1 1
NCT03384186A Study of Modified Release Formulations of Danicopan in Healthy Adult ParticipantsHealthy
COMPLETED14 Analytics
PHASE1COMPLETED
A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants
Healthy
NCT0338418614
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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 to 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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Frequently asked questions about Danicopan Modified Release Prototype 1

What is Danicopan Modified Release Prototype 1 used for?

Danicopan Modified Release Prototype 1 is an investigational small molecule being studied in healthy adult participants. It is a modified release formulation of danicopan, and the completed Phase 1 trial evaluated it in healthy volunteers to assess its properties. It is not approved for any disease and remains in clinical development.

Who makes Danicopan Modified Release Prototype 1?

Danicopan Modified Release Prototype 1 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored a Phase 1 clinical trial of this modified release formulation in healthy participants in the United Kingdom.

What phase is Danicopan Modified Release Prototype 1 in?

Danicopan Modified Release Prototype 1 is in Phase 1 clinical development. The single trial, NCT03384186, has been completed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Danicopan Modified Release Prototype 1 in?

Danicopan Modified Release Prototype 1 was studied in one completed Phase 1 trial, NCT03384186, titled "A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants." The trial enrolled 14 healthy adults in the United Kingdom and was not randomized or blinded.

Is Danicopan Modified Release Prototype 1 the same as danicopan?

Danicopan Modified Release Prototype 1 is a modified release formulation of the drug danicopan. The Phase 1 trial evaluated this specific prototype in healthy participants to study its release characteristics. Danicopan itself is the active pharmaceutical ingredient in this formulation.