Study to Collect Samples for MIST Analysis of Zibotentan and Bioavailability of Zibotentan and Dapagliflozin in Heatlhy Participants

Conditions

• Chronic Kidney Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• Zibotentan (Treatment A) — DRUG
  Zibotentan capsule will be administered orally as multiple doses in Part 1 and as single dose in Part 2.
• Dapagliflozin (Treatment A) — DRUG
  Dapagliflozin tablet will be administered orally as single dose in Part 2.
• Zibotentan/Dapagliflozin - Formulation 1 (Treatment B) — DRUG
  Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2.
• Zibotentan/Dapagliflozin - Formulation 2 (Treatment C) — DRUG
  Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2.

Study Details

The study will have 2 independent parts: Part 1 of the study is intended to collect samples for Metabolites in Safety Testing (MIST) analysis after administration of multiple doses of zibotentan. Part 2 of the study is designed to evaluate the relative bioavailability of zibotentan and dapagliflozin after dosing with two different fixed-dose combination (FDC) formulations and dosing with separate formulations of zibotentan and dapagliflozin.

Key Dates

First listed

Aug 5, 2021

Start date

Jul 29, 2021

Status verified

Nov 2021

Primary completion

Oct 22, 2021

Completion

Oct 22, 2021

Study Design

Enrollment

27 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Part 1
  Participants will be administered with zibotentan once daily for 5 days.
• Experimental: Part 2: Treatment Sequence ABC
  Each participant will receive 3 single-dose treatments of zibotentan and dapagliflozin (Treatment A; Treatment B; Treatment C) in 3 treatment periods, separated by a washout period of at least 7 days between treatment periods.
• Experimental: Part 2: Treatment Sequence BCA
  Each participant will receive 3 single-dose treatments of zibotentan and dapagliflozin (Treatment B; Treatment C; Treatment A) in 3 treatment periods, separated by a washout period of at least 7 days between treatment periods.
• Experimental: Part 2: Treatment Sequence CAB
  Each participant will receive 3 single-dose treatments of zibotentan and dapagliflozin (Treatment C; Treatment A; Treatment B) in 3 treatment periods, separated by a washout period of at least 7 days between treatment periods.

Primary Outcome Measure

Part 1: Metabolites in Safety Testing sampling [ Time Frame: Day 1 through Day 6 (pre-dose, 30 min; 1, 2, 4, 6, 8, 12 and 24 hours post dose) ]

Locations (1)

Find similar trials in Brooklyn, MD

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