AZD9977, - Safety | Phase 1 | AstraZeneca PLC | BiopharmaWatch

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AZD9977,

Phase 1

Safety | Small molecule | Other |AstraZeneca PLC|Last Updated: Apr 28, 2017

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

RandomizedPLACEBO_CONTROLLEDBiomarker

Total Trials1

Total Enrollment196

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT02484729	A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 After Single Ascending Doses to Healthy Males	PHASE1	COMPLETED	196	—	—	Jul 1, 2015	Nov 1, 2015	Apr 28, 2017	1	United Kingdom

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Study Endpoints

Primary Endpoints

Safety and Tolerability of AZD9977 by Assessing the Percentage of Participants With Adverse Events

For up to 45 days, i.e. from Screening to Follow-up

To assess the safety and tolerability of single ascending doses of AZD9977

Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Pulse Rate

For up to 45 days, i.e. from Screening to Follow-up

To assess the safety and tolerability of single ascending doses of AZD9977

Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Trends in 12-lead Electrocardiograms

For up to 45 days, i.e. from Screening to Follow-up

To assess the safety and tolerability of single ascending doses of AZD9977

Safety and Tolerability of AZD9977 by Number of Participants With Clinically Significant Trends in Cardiac Telemetry

For up to 4 days, i.e. on the day before each dosing and for 24 hours after each dosing

To assess the safety and tolerability of single ascending doses of AZD9977

Safety and Tolerability of AZD9977 by Assessing the Number of Subjects With Adverse Events

For up to 45 days, i.e. from Screening to Follow-up

To assess the safety and tolerability of single ascending doses of AZD9977

Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Blood Pressure

For up to 45 days, i.e. from Screening to Follow-up

To assess the safety and tolerability of single ascending doses of AZD9977

Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Hematology

For up to 45 days, i.e. from Screening to Follow-up

To assess the safety and tolerability of single ascending doses of AZD9977

Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Clinical Chemistry

For up to 45 days, i.e. from Screening to Follow-up

To assess the safety and tolerability of single ascending doses of AZD9977

Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Urinalysis

For up to 45 days, i.e. from Screening to Follow-up

To assess the safety and tolerability of single ascending doses of AZD9977

Secondary Endpoints

Area Under the Plasma Concentration Versus Time Curve (AUC) From Zero Extrapolated to Infinity.

Pre-dose and post-dose upto 48 hrs

Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte concentrationAUC(0-t)

Pre-dose and post-dose upto 48 hrs

Observed Maximum Concentration (Cmax)

Pre-dose and post-dose upto 48 hrs

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Study Design & Arms

AllocationRANDOMIZED

MaskingSINGLE

ModelPARALLEL

PurposeBASIC_SCIENCE

Treatment Arms

Arm	Type	Description
AZD9977 oral suspension, single doses	EXPERIMENTAL	In Part A up to 10 cohorts with single ascending doses with AZD9977 as oral suspension. In Part B AZD9977 as oral suspension in IntelliCap® capsule
Placebo, oral suspension, single doses	PLACEBO_COMPARATOR	In Part A up to 10 cohorts with single doses with matching placebo to AZD9977
AZD9977, oral solution, single dose	EXPERIMENTAL	In Part B, of oral solution of AZD9977 will be used as reference

Interventions

Name	Type	Description
AZD9977, oral suspension	DRUG	Single ascending doses of AZD9977 oral suspension (Part A) Single dose of AZD9977 oral suspension in IntelliCap® capsule in regional absorption part (Part B)
Placebo, oral suspension	DRUG	Matching placebo
AZD9977, oral solution	DRUG	AZD9977, single dose of oral solution in Part B as reference

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Eligibility Criteria

Age Range18 Years — 50 Years

SexMALE

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: 1. Provision of signed and dated written informed consent prior to any study specific procedures. 2. Healthy male subjects aged 18 to 50 years with suitable veins for cannulation or repeated venipuncture. 3. Male subjects have to comply with the restrictions for sexual activity ...

Countries:United Kingdom

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