A Phase I Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-17

Study Completion Date

2025-04-20

Brief Summary

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This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function.

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Detailed Description

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This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function.

Participants will be assigned to the following groups based on eGFR determined at screening by a local laboratory using serum creatinine:

Group 1: Participants with severe renal impairment (eGFR \< 30 mL/min), not on dialysis.

Group 2: Participants with normal renal function (eGFR of ≥ 90 mL/min) matched by sex, age, and body weight on a group level to the impaired participants.

Group 3 (optional): Participants with moderate renal impairment (eGFR ≥ 30 to \< 60 mL/min).

Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Up to three groups (two renal impairment groups and controls with normal renal function) will be enrolled into this study.

All subjects will receive the study intervention:

Group 1 will enroll 7 participants with severe renal impairment Group 2 will enroll \~7 participants with normal renal function matched by sex, age, and body weight Group 3 (optional) will enroll 7 participants with moderate renal impairment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Participants with severe renal impairment will receive a single oral dose of AZD5004 under fasted conditions.

Group Type EXPERIMENTAL

AZD5004

Intervention Type DRUG

Dose 1

Group 2

Participants with normal renal function will receive a single oral dose of AZD5004 under fasted conditions.

Group Type EXPERIMENTAL

AZD5004

Intervention Type DRUG

Dose 1

Group 3 (Optional)

Participants with moderate renal impairment will receive a single oral dose of AZD5004 under fasted conditions.

Group Type EXPERIMENTAL

AZD5004

Intervention Type DRUG

Dose 1

Interventions

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AZD5004

Dose 1

Intervention Type DRUG

Other Intervention Names

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ECC5004 Dose 1

Eligibility Criteria

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Inclusion Criteria

* Adults 18-80 years of age
* Weight \>50kg and BMI between 18-40 kg/m2

For participants with normal renal function:

-Participant must be medically healthy with no significant findings on medical evaluation and an eGFR ≥90 ml/min at screening.

For participants with renal impairment:

Group 1 (severe) must have an eGFR \<30 ml/min and Group 3 (moderate) must have an eGFR 30 to \<60 ml/min based on CKD-EPI calculations for at least 6 months prior to enrollment.

Exclusion Criteria

* Poorly controlled diabetes mellitus (A1C \>10% at screening or recent history of diabetic ketoacidosis or symptomatic hypoglycemia).
* Unwillingness to use adequate contraception
* Uncontrolled hypertension or hypotension.
* Positive screening for HIV, Hepatitis B, or Hepatitis C
* Presence of unstable systemic disease or psychologic conditions. Abnormal laboratory values to include but not limited to liver function tests (thresholds differ for renal impairment and health controls)
* Any change in baseline medication within 2 weeks of planned study initiation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes