Clinical trial NCT06742762: A Phase I Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004
Official title: A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: Renal Impairment
Healthy participants
AZD5004
Pharmacokinetics
Safety
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-12-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: AUCinf
timeFrame: Day 1 to Day 5
measure: AUClast
timeFrame: Day 1 to Day 5
measure: Cmax
timeFrame: Day 1 to Day 5
Secondary outcomes:
measure: Tmax
timeFrame: Day 1 to Day 5
measure: PK parameter t1/2λz
timeFrame: Day 1 to Day 5
measure: PK parameter CL/F
timeFrame: Day 1 to Day 5
measure: PK parameter CLNR/F
timeFrame: Day 1 to Day 5
measure: PK parameter Vz/F
timeFrame: Day 1 to Day 5
measure: PK parameter CLr
timeFrame: Day 1 to Day 5
measure: PK parameter Ae
timeFrame: Day 1 to Day 5
measure: fe
timeFrame: Day 1 to Day 5
Other outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Day 1 to Day 10
measure: Number of participants with abnormal Vital signs, abnormal ECGs, and abnormal physical examination findings
timeFrame: Day 1 to Day 5
measure: Number of participants with abnormal laboratory tests results
timeFrame: Day 1 to Day 5
Locations:
city: Miami Lakes
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
Study officials:
References: