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: Antacids, Analgesics, others

Disqualifiers: Pancreatitis, Renal disease, Psychosis, others

Compensation: Varies

Number of Visits: Unknown

31 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to assess the safety, tolerability, and pharmacokinetic (PK) of AZD5004 administered as multiple oral doses in healthy participants and to compare the relative bioavailability of two oral tablet strengths of AZD5004.

Eligibility Criteria

This trial is for healthy individuals who want to participate in a study assessing the safety of a new medication. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and cannot have conditions that would exclude them from safely participating.

Inclusion Criteria

I am using a reliable form of birth control that is not the pill.

I haven't taken statins for at least 4 weeks.

My veins can be used for needle insertions.

Exclusion Criteria

I have a history of stomach, liver, or kidney disease.

I have a serious liver condition, bowel inflammation, stomach paralysis, or have had major upper GI tract surgery.

I have a history of a significant health condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment Part A

Participants receive repeated dosing of AZD5004 or placebo to assess safety, efficacy, tolerability, and pharmacokinetics

15 weeks

Follow-up Part A

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Part B

Two-way cross-over study to compare the relative bioavailability of two oral tablet strengths of AZD5004

2 weeks

Follow-up Part B

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• AZD5004

Trial Overview The trial is testing AZD5004, given as multiple oral doses, against a placebo (a substance with no active drug). It aims to understand how safe AZD5004 is and how it's processed by the body when taken more than once.

Participant Groups

Group I: Part B: Treatment 2 (AZD5004) Experimental Treatment 1 Intervention

Participants in Group 1 will receive Treatment 1 of AZD5004 and then Treatment 2 of AZD5004. Participants in Group 2 will receive Treatment 2 of AZD5004 and then Treatment 1 of AZD5004.

Group II: Part B: Treatment 1 (AZD5004) Experimental Treatment 1 Intervention

Participants in Group 1 will receive Treatment 1 of AZD5004 and then Treatment 2 of AZD5004. Participants in Group 2 will receive Treatment 2 of AZD5004 and then Treatment 1 of AZD5004.

Group III: Part A: Multiple Ascending dose (MAD) (AZD5004) Experimental Treatment 1 Intervention

Participants will receive repeated dosing of AZD5004 orally.

Group IV: Part A: Placebo Placebo Group 1 Intervention

Participants will receive matching Placebo orally.

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