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Anti-tumor antibiotic

AZD5004 for Healthy Subjects

Phase 1

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have suitable veins for cannulation or repeated venipuncture

Must have a body mass index ≥ 23 kg/m2 and not exceeding 35 kg/m2 inclusive and weigh at least 60 kg

Must not have

History or presence of gastrointestinal, hepatic, or renal disease

Clinically significant hepatic disease, inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper gastrointestinal tract

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day - 2) to days 49, 91, and 106

Summary

"This trial aims to see how safe and well-tolerated AZD5004 is when given in multiple doses by mouth to healthy volunteers."

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is an early-stage trial for AZD5004 in healthy volunteers, potential side effects are being investigated. Commonly, such trials look out for any adverse reactions ranging from mild symptoms like headaches or nausea to more serious ones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My veins can be used for needle insertions.

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My BMI is between 23 and 35, and I weigh at least 60 kg.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have not had psychosis, major depression, or suicidal thoughts or attempts in the last year.

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My thyroid disease is not under control.

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I have had pancreatitis, gallstones, or high levels of specific digestive enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day - 2) to days 49, 91, and 106

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day - 2) to days 49, 91, and 106

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day - 2) to days 49, 91, and 106 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Part B: Area under concentration-time curve from time 0 to infinity (AUCinf)

Part B: Area under the concentration-curve from time zero to the last quantifiable concentration (AUClast)

+2 more

Secondary study objectives

Part A: Absolute change from Baseline in BMI (kg/m^2)

Part A: Absolute change from Baseline in body weight (kg)

Part A: Amount of unchanged drug excreted into urine from time t1 to time t2 (Ae[t1-t2])

+8 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B: Treatment 2 (AZD5004)Experimental Treatment1 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 Treatment1 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 Treatment1 Intervention

Participants will receive repeated dosing of AZD5004 orally.

Group IV: Part A: PlaceboPlacebo Group1 Intervention

Participants will receive matching Placebo orally.

0 / 8Eligibility criteria met