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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: AZD5004

Study type: Interventional

Funder types: Industry

Identifiers

NCT06742762

D7260C00006

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: AZD5004

Group 2

Experimental group

Description:

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

Treatment:

Drug: AZD5004

Group 3 (Optional)

Experimental group

Description:

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

Treatment:

Drug: AZD5004