Multiple-ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 in Healthy Male Subjects

Healthy Volunteers Clinical Trial

Official title: A Phase 1, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 Following Multiple-Ascending Dose Administration in Healthy Volunteers

Status Completed

Clinical Trial Summary

This is a randomized, single-blind, placebo-controlled study conducted on healthy male subjects at a single study center to assess the safety, tolerability and the pharmacokinetics of AZD9977 following multiple-ascending oral doses at steady state

Clinical Trial Description

This is a phase 1, randomized, single-blind, placebo-controlled, single center, multiple-ascending dose sequential-group design study conducted on 45 healthy male subjects to investigate the safety, tolerability, pharmacokinetics (PK) of AZD9977, time to reach steady state, the degree of accumulation and the time dependency of the PK. The study consists of three visits:

• A screening period (maximum 28 days)

• A treatment period (subjects will be resident from 2 days before first dose of investigation medicinal product (IMP) (Day -2) until at least 36 after last dose of IMP and will be discharged on Day 9) and

• A follow-up visit within 5 to 7 days after last dose of IMP. This study consists of 3 Cohorts (9 subjects each). Based on the safety review committee (SRC) requirement, 2 additional cohorts may be added either to repeat a dose level or additional dose steps, if required. In each cohort, subjects will be randomized to receive AZD9977 (6 subjects) and placebo (3 subjects) oral suspension twice daily. The dose of AZD9977 in Cohort 1 will be 50 mg as starting dose and in Cohort 2 and 3 at provisional dose 150 mg and 300 mg, respectively. Each subject will receive a total of 14 oral doses of AZD9977 or placebo. Each subject will receive a single dose of IMP in the morning of Day 1 and Day 8 and twice daily doses on Day 2 to Day 7.

On Day 1 and Day 8, subjects will be fasted for 10 hours before dosing until 4 hours after dosing when lunch will be served. On Day 2 to Day 6, subjects will be fasted for 10 hours before dosing until 1 hour after dosing when breakfast will be served. On Day 7, subjects will be fasted for 10 hours before dosing and until after the completion of the oral glucose tolerance test (OGTT) when breakfast will be served. For the evening dose of IMP (Days 2 to Day 7), subjects will be fasted for 2 hours before dosing until 1 hour after dosing. On all days, subjects will be allowed to drink freely until 1 hour before dosing to prevent dehydration before each morning and evening dose and water consumption could be resumed 1 hour after dosing.

Dosing for each ascending dose cohort will proceed with 2 subjects in a sentinel cohort, such that 1 subject will be randomized to receive placebo and 1 subject will be randomized to receive AZD9977. The safety data from the sentinel subjects up to 72 hours post first dose will be reviewed by the principal investigator (PI) before the remaining subjects in the cohort are dosed. Following review of data from the study, the SRC may decide to adjust the length of the stay at the study site and the timing and number of assessments and/or blood samples for subsequent cohorts. The time window between the single dose and start of repeated dosing may also be adjusted. The duration of the study is approximately 6 weeks ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT03435276
• Study type: Interventional
• Source: AstraZeneca
• Status: Completed
• Phase: Phase 1
• Start date: February 27, 2018
• Completion date: June 13, 2018