AZD4635 Relative Bioavailability Study — Rel Bio  

Healthy Volunteers Clinical Trial

Official title: A Phase I, Open-Label Study to Assess the Pharmacokinetics and Relative Bioavailability of AZD4635 in Non-Smoking Healthy Male Subjects, With the Option to Assess Food Effect, pH Effect and Absolute Bioavailability

Status Completed

Clinical Trial Summary

To investigate the pharmacokinetics and relative bioavailability of AZD4635 solid oral formulation and compare with the nano-suspension reference formulation with the option to assess food effect, pH effect and absolute bioavailability

Clinical Trial Description

This is a single centre, phase 1, open-label randomised, 2-part study to assess the pharmacokinetics and relative bioavailability of AZD4635 in non-smoking healthy male subjects, with the option to assess food effect, pH effect and absolute bioavailability. It is planned to enrol 20 subjects who will participate in both parts of the study. Subjects will receive a single-dose of AZD4635 in 6 dosing periods with a minimum washout of 9 days between doses.

Part A is a 2-period randomised crossover study of single doses of AZD4635. Subjects will be randomised to receive 50mg AZD4635 nano-suspension (reference) or 50mg AZD4635 solid oral formulation, in the fasted state.

Part B is a 4-period, open-label, randomised, crossover study of single doses of AZD4635 in the same subjects from Part A. The treatments selected for Part B will depend on the outcome of interim analyses of AZD4635 exposure. Subjects will receive 2 of the following 4 treatments in dosing periods 3 and 4:

• A single dose of AZD4635 solid oral formulation dose after a high fat meal

• A single dose of AZD4635 solid oral formulation co-administered with a proton pump inhibitor (PPI), lansoprazole (fasted state)

• A different single dose (XX mg) of AZD4635 solid oral formulation (fasted state)

• Another different single dose (YY mg) of AZD4635 solid oral formulation (fasted state)

Periods 5 and 6 is a 2-period randomised crossover of two variants of AZD4635 solid oral formulation. Subjects will be randomised to receive AZD4635 solid oral formulation variant 1 in the fasted state or AZD4635 solid oral formulation variant 2 in the fasted state. In Periods 5 and 6, Part B an IV microtracer dose of [14C] AZD4635 with solid oral formulation, variant 1 will be administered. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT03710434
• Study type: Interventional
• Source: AstraZeneca
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2018
• Completion date: April 2, 2019