Recently added Catalysts

Capivasertib film-coated

Phase 1

Healthy Volunteer | Small molecule | Other |AstraZeneca PLC|Last Updated: Jul 22, 2022

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED

Total Trials1

Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

Capivasertib film-coated · 1 trial · 1 indication

Phase 1 1

NCT05419401A Study to Investigate the Absolute Bioavailability, Absorption, Metabolism, Distribution and Excretion of [14C]AZD5363 (Capivasertib)Healthy Volunteer

COMPLETED7 Analytics

PHASE1COMPLETED

A Study to Investigate the Absolute Bioavailability, Absorption, Metabolism, Distribution and Excretion of [14C]AZD5363 (Capivasertib)

Healthy Volunteer

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Study Endpoints

Primary Endpoints

Absolute bioavailability (F)

Plasma sample collection from pre-dose to 72 hours post dose

Absolute bioavailability (F) of oral capivasertib compared to \[14C\]-capivasertib (part 1)

tmax

Plasma sample collection from pre-dose to 72 hours post dose

PK of capivasertib and \[14C\]AZD5363 (capivasertib) in plasma (part 1)

Cmax

Plasma samples collection from pre-dose to 72 hours post dose

PK of capivasertib and \[14C\]AZD5363 (capivasertib) in plasma (part 1)

AUC0-t

Plasma samples collection from pre-dose to 72 hours post dose

PK of capivasertib and \[14C\]AZD5363 (capivasertib) in plasma (Part 1)

AUC0-inf

Plasma samples collection from pre-dose to 72 hours post dose

PK of capivasertib and \[14C\]AZD5363 (capivasertib) in plasma (Part 1)

t1/2

Plasma samples collection from pre-dose to 72 hours post dose

PK of capivasertib and \[14C\]AZD5363 (capivasertib) in plasma (Part 1)

λz

Plasma samples collection from pre-dose to 72 hours post dose

PK of capivasertib and \[14C\]AZD5363 (capivasertib) in plasma (Part 1)

CL/F

Plasma samples collection from pre-dose to 72 hours post dose

PK of capivasertib and \[14C\]AZD5363 (capivasertib) in plasma (Part 1)

Vz/F

Plasma samples collection from pre-dose to 72 hours post dose

PK of capivasertib and \[14C\]AZD5363 (capivasertib) in plasma (Part 1)

CLR

Plasma sample collection from pre-dose to 72 hours post dose and urine samples collected from pre-dose until 168 hours post-dose

PK (plasma and urine) and total radioactivity (whole blood and plasma) of capivasertib (Part 2)

CumAe

Urine and faecal samples collected from pre-dose until 168 hours post-dose

Mass balance recovery of \[14C\]AZD5365 (capivasertib) from urine and faecal samples (Part 2)

Cum%Ae

Urine and faecal samples collected from pre-dose until 168 hours post-dose

Mass balance recovery of \[14C\]AZD5365 (capivasertib) from urine and faecal samples (Part 2)

Ae

Urine and faecal sample collection from pre-dose until 168 hours post-dose

Mass balance recovery of \[14C\]AZD5365 (capivasertib) from urine and faecal samples (Part 2)

%Ae

Urine and faecal sample collection from pre-dose until 168 hours post-dose

Mass balance recovery of \[14C\]AZD5365 (capivasertib) from urine and faecal samples (Part 2)

Blood:plasma concentration ratios

Whole blood samples collected up to 24 hours post dose. Plasma sample collection from pre-dose until 72 hours post-dose

Blood:plasma concentration ratios of total radioactivity (Part 2)

Secondary Endpoints

Number of subjects with treatment-related adverse events

Through study duration, an average of 9 weeks.

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Study Design & Arms

AllocationNA

MaskingNONE

ModelSEQUENTIAL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Capivasertib	EXPERIMENTAL	film-coated tablet, 200 mg
[14C]AZD5363 (Capivasertib)	EXPERIMENTAL	Solution for Infusion 20 µg/mL (NMT 37.0 kBq/5 mL) and Oral Solution, 400 mg (NMT 4.8 MBq)

Interventions

Name	Type	Description
Capivasertib film-coated tablet, 200 mg	DRUG	400mg dose, oral, fasted
[14C]AZD5363 (Capivasertib)	DRUG	Solution for Infusion 20 µg/mL (NMT 37.0 kBq/5 mL) - 100 µg; 5 mL, Intravenous Oral Solution, 400 mg (NMT 4.8 MBq) - 400mg; 100mL, oral, fasted

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Eligibility Criteria

Age Range30 Years to 65 Years

SexMALE

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures. * Must be willing and able to communicate and participate in the whole study. * Healthy males aged 30 to 65 years inclusive at the time of signing informed consent. * Must be vasect...

Countries:United Kingdom

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Frequently asked questions about Capivasertib film-coated

What is Capivasertib film-coated used for?

Capivasertib film-coated is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development. The drug is not approved for any indication and remains under investigation.

Who makes Capivasertib film-coated?

Capivasertib film-coated is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's properties in healthy volunteers.

What phase is Capivasertib film-coated in?

Capivasertib film-coated is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in a single completed Phase 1 trial involving healthy volunteers.

What clinical trials is Capivasertib film-coated in?

Capivasertib film-coated has one completed clinical trial, NCT05419401, titled 'A Study to Investigate the Absolute Bioavailability, Absorption, Metabolism, Distribution and Excretion of [14C]AZD5363 (Capivasertib)'. This Phase 1 study enrolled 7 healthy male volunteers in the United Kingdom.

Is Capivasertib film-coated the same as AZD5363?

Yes, Capivasertib film-coated is also known as AZD5363. The clinical trial NCT05419401 refers to the drug as [14C]AZD5363 (Capivasertib), confirming that AZD5363 is an alternative name for the same investigational drug.