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A Study to Assess the Pharmacodynamic Effect of Single Doses of AZD9977 in Healthy Male Subjects

NCT02532998 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-03-29

Study results available
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Summary

This is a Phase I, Randomized, Single-Blind, Crossover Study to Assess the Pharmacodynamics of AZD9977 following Single-Dose administration to healthy male subjects

Conditions

  • Pharmacodynamics
  • Healthy Subjects

Interventions

DRUG

AZD9977 oral suspension

AZD9977 oral suspension, single dose

DRUG

AZD9977 placebo oral suspension

oral suspension, single dose

DRUG

Fludrocortisone, tablets

Loading dose of 0.5 mg and maintenance doses of 0.1 mg every second hour up to a total dose of 1.0 mg per treatment period (may be modified to up to 1.3 mg based on emerging data)

DRUG

Eplerenone, tablets

100 mg (2 x 50 mg tablets) single dose, may be modified based on emerging data (will not exceed 500 mg per treatment period)

Sponsors & Collaborators

Principal Investigators

  • Muna Albayaty, MBChB, MSc, MFPM · PAREXEL Early Phase Clinical Unit London

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02532998 on ClinicalTrials.gov