Study identifier:D6401C00001
ClinicalTrials.gov identifier:NCT03435276
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 Following Multiple-Ascending Dose Administration in Healthy Volunteers
Healthy Volunteers
Phase 1
Yes
AZD9977
Male
27
Interventional
18 Years - 50 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Mar 2019 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Cohort 1 Randomized subjects will receive AZD9977 50 mg or placebo oral suspension single dose on Day 1 and Day 8; twice daily dose Day 2 to Day 7 | Drug: AZD9977 Randomized subjects will receive AZD9977 oral suspension at a dose of 50 mg in Cohort 1, 150 mg in Cohort 2 and 300 mg in Cohort 3 Other: Placebo Randomized subjects will receive orally AZD9977 matched placebo in Cohorts 1, 2 and 3 |
Experimental: Cohort 2 Randomized subjects will receive AZD9977 150 mg or placebo oral suspension single dose on Day 1 and Day 8; twice daily dose on Day 2 to Day 7 | Drug: AZD9977 Randomized subjects will receive AZD9977 oral suspension at a dose of 50 mg in Cohort 1, 150 mg in Cohort 2 and 300 mg in Cohort 3 Other: Placebo Randomized subjects will receive orally AZD9977 matched placebo in Cohorts 1, 2 and 3 |
Experimental: Cohort 3 Randomized subjects will receive AZD9977 300 mg or placebo oral suspension single dose on Day 1 and Day 8; twice daily dose on Day 2 to Day 7 | Drug: AZD9977 Randomized subjects will receive AZD9977 oral suspension at a dose of 50 mg in Cohort 1, 150 mg in Cohort 2 and 300 mg in Cohort 3 Other: Placebo Randomized subjects will receive orally AZD9977 matched placebo in Cohorts 1, 2 and 3 |