Study identifier:D7960C00007
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Single-Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD0780
Renal Impairment
Phase 1
Yes
AZD0780
All
32
Interventional
18 Years - 85 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Other: Group 1 Participants with severe renal impairment (eGFR < 30 mL/min), not on dialysis. | Drug: AZD0780 - Dose formulation: Tablet - Unit dose strength: "B" - Dosage level: "A", single dose (2 × "B"-mg tablets) - Route of administration: Oral -Use: Experimental -IMP or NIMP: IMP -Sourcing: Provided centrally by the sponsor, AstraZeneca (or subsidiary or designee) -Packaging and labelling: AZD0780 will be provided in an HDPE bottle, labelled in accordance with national laws and regulations. The AZD0780 tablets will be provided in an open-label, participant specific bottle. A single "A" dose of AZD0780 (2 × "B" tablets) will be administered in the morning on Day 1 under fasted condition. Study intervention will be administered orally with approximately 240 mL of water. |
Other: Group 2 Participants with ESRD (eGFR < 15 mL/min) on a stable intermittent HD schedule for at least 3 months prior to planned dosing. | Drug: AZD0780 - Dose formulation: Tablet - Unit dose strength: "B" - Dosage level: "A", single dose (2 × "B"-mg tablets) - Route of administration: Oral -Use: Experimental -IMP or NIMP: IMP -Sourcing: Provided centrally by the sponsor, AstraZeneca (or subsidiary or designee) -Packaging and labelling: AZD0780 will be provided in an HDPE bottle, labelled in accordance with national laws and regulations. The AZD0780 tablets will be provided in an open-label, participant specific bottle. A single "A" dose of AZD0780 (2 × "B" tablets) will be administered in the morning on Day 1 under fasted condition. Study intervention will be administered orally with approximately 240 mL of water. |
Other: Group 3 Participants with normal renal function demographically matched by sex, age, and body mass index (BMI) to the impaired participants (eGFR of ≥ 90 mL/min) | Drug: AZD0780 - Dose formulation: Tablet - Unit dose strength: "B" - Dosage level: "A", single dose (2 × "B"-mg tablets) - Route of administration: Oral -Use: Experimental -IMP or NIMP: IMP -Sourcing: Provided centrally by the sponsor, AstraZeneca (or subsidiary or designee) -Packaging and labelling: AZD0780 will be provided in an HDPE bottle, labelled in accordance with national laws and regulations. The AZD0780 tablets will be provided in an open-label, participant specific bottle. A single "A" dose of AZD0780 (2 × "B" tablets) will be administered in the morning on Day 1 under fasted condition. Study intervention will be administered orally with approximately 240 mL of water. |
Other: Group 4 (optional) Participants with moderate renal impairment (eGFR ≥ 30 to < 60 mL/min). | Drug: AZD0780 - Dose formulation: Tablet - Unit dose strength: "B" - Dosage level: "A", single dose (2 × "B"-mg tablets) - Route of administration: Oral -Use: Experimental -IMP or NIMP: IMP -Sourcing: Provided centrally by the sponsor, AstraZeneca (or subsidiary or designee) -Packaging and labelling: AZD0780 will be provided in an HDPE bottle, labelled in accordance with national laws and regulations. The AZD0780 tablets will be provided in an open-label, participant specific bottle. A single "A" dose of AZD0780 (2 × "B" tablets) will be administered in the morning on Day 1 under fasted condition. Study intervention will be administered orally with approximately 240 mL of water. |