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AZD8108 SAD/MAD in Healthy Volunteers

NCT ID: NCT02248818

Last Updated: 2017-04-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-09-30

Brief Summary

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This is a randomized, double-blind, placebo-controlled study of single and multiple ascending dosage levels of AZD8108 in healthy volunteers. The study includes an up to 28-day screening period, an in-house period during which AZD8108 or placebo will be administered orally as a solution, and a 4- to 10-day follow-up period after discharge.

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Detailed Description

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In Part 1 of the study (single ascending dose portion), approximately 32 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 4 dosage-level cohorts (AZD8108 or placebo). Within each cohort, 6 subjects will be randomized to receive AZD8108 and 2 subjects will be randomized to receive placebo. Each subject will receive only one dose of either AZD8108 or placebo on Day 1. In Part 2 of the study (multiple ascending dose portion), approximately 24 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 3 dosage-level cohorts. Within each cohort, 6 subjects will be randomized to receive AZD8108 and 2 subjects will be randomized to receive placebo. Each subject will receive twelve doses of either AZD8108 or placebo

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AZD8108

Subjects will participate in 1 of 7 groups and receive single or multiple doses of AZD8108 or matching placebo. In each group 6 subjects will receive AZD8108

Group Type EXPERIMENTAL

AZD8108

Intervention Type DRUG

Drug: AZD8108 Single or Multiple doses administered orally as a solution.

Placebo to match AZD8108

Subjects will participate in 1 of 7 groups and receive single or multiple doses of AZD8108 or matching placebo. In each group 2 subjects will receive matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match AZD8108 Single or Multiple doses of matching placebo administered orally as a solution

Interventions

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AZD8108

Drug: AZD8108 Single or Multiple doses administered orally as a solution.

Intervention Type DRUG

Placebo

Placebo to match AZD8108 Single or Multiple doses of matching placebo administered orally as a solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mina Pastagia, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Clinilabs, Inc.

Locations

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Clinilabs, Inc.

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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D5800C00001

Identifier Type: -

Identifier Source: org_study_id

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