AZD5004 for Healthy Subjects

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Antidepressants, Antipsychotics, others

Disqualifiers: Pancreatitis, GI disease, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

16 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the relative bioavailability of a single dose AZD5004 in healthy participants, among 3 different oral tablet formulations.

Eligibility Criteria

This trial is for healthy individuals who meet specific health criteria set by the study's guidelines. The exact inclusion and exclusion criteria are not provided, but typically participants must have no significant medical conditions and be within a certain age range.

Inclusion Criteria

I cannot become pregnant.

I have veins suitable for repeated needle insertions.

Additional contraception must be used for the sexual partners of male study participants throughout the clinical study

Exclusion Criteria

I have no major illnesses or recent surgeries.

Known or suspected history of alcohol or drug abuse or excessive intake of alcohol

Excessive intake of caffeine-containing drinks or food

Timeline

Screening

Participants are screened for eligibility to participate in the trial

27 days

Treatment Period 1

Participants receive a single dose of AZD5004 in one of the formulations (F1, F3, or F4) under fasted or fed conditions

7 days

1 visit (in-person)

Treatment Period 2

Participants receive a single dose of AZD5004 in one of the formulations (F1, F3, or F4) under fasted or fed conditions

7 days

1 visit (in-person)

Treatment Period 3

Participants receive a single dose of AZD5004 in one of the formulations (F1, F3, or F4) under fasted or fed conditions

7 days

1 visit (in-person)

Treatment Period 4

Participants receive a single dose of AZD5004 in one of the formulations (F1, F3, or F4) under fasted or fed conditions

7 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 to 10 days

1 visit (in-person)

Treatment Details

Interventions

• AZD5004

Trial Overview The study is testing the relative bioavailability of AZD5004, which means it's looking at how well the drug is absorbed and becomes available in the body when taken as three different oral tablet formulations.

Participant Groups

Group I: Treatment Sequence D Experimental Treatment 1 Intervention

Participants will receive single dose of AZD5004 on Day 1 in F3 (fasted) (Treatment Period 1), Day 8 in F1 (fasted) (Treatment Period 2), on Day 15 in F4 (fasted) (Treatment Period 3) followed by Day 22 in F4 (fed) (Treatment Period 4) respectively.

Group II: Treatment Sequence C Experimental Treatment 1 Intervention

Participants will receive single dose of AZD5004 on Day 1 in F4 (fed) (Treatment Period 1), on Day 8 in F3 (fasted) (Treatment Period 2, on Day 15 in F1 (fasted) (Treatment Period 3 followed by on Day 22 in F4 (fasted) (Treatment Period 4) respectively.

Group III: Treatment Sequence B Experimental Treatment 1 Intervention

Partcipants will receive single dose of AZD5004 on Day 1 in F4 (fasted) (Treatment Period 1), on Day 8 in F4 (fed) (Treatment Period 2), on Day 15 in F3 (fasted) (Treatment Period 3) followed by on Day 22 in F1 (fasted) (Treatment Period 4) respectively.

Group IV: Treatment Sequence A Experimental Treatment 1 Intervention

Participants will receive single dose of AZD5004 on Day 1 in F1 (fasted) (Treatment period 1), on Day 8 in F4 (fasted) (Treatment period 2), on Day 15 in F4(fed) (Treatment Period 3) followed by on Day 22 in F3 (fasted) (Treatment Period 4) respectively.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland