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A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of AZD9898

NCT03140072 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-01-17

No results posted yet for this study

Summary

In this integrated, multi-part, Phase I study, the safety, tolerability, food effect, pharmacokinetic (PK) and pharmacodynamic (PD) properties of single and repeated doses of AZD9898 will be investigated.

Conditions

Interventions

DRUG

AZD9898

In Parts 1 and 2 of the study, each subject/patient will receive a single dose (one dose level) of AZD9898, under fasted conditions. Starting dose in part 1 (SAD in healthy subjects) is 3 mg, subsequent doses will be selected based on emerging data. In Part 3 of the study, each subject will receive one dose level of AZD9898, once daily, under fasted or fed conditions. Subjects participating in Part 3B (food effect cohort) will receive an additional administration of the same dose, on the last day to investigate the effects of food.

DRUG

Matching Placebo

In Parts 1 and 2 of the study, each subject/patient will receive a single dose (one dose level) of matching placebo, under fasted conditions. In Part 3 of the study, each subject will receive one dose level of matching placebo, once daily, under fasted or fed conditions. Subjects participating in Part 3B (food effect cohort) will receive an additional administration of the same dose, on the last day to investigate the effects of food.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Muna Albayaty · PAREXEL Early Phase Clinical Unit London

  • Dave Singh · The Medicines Evaluation Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-10
Primary Completion
2017-08-23
Completion
2017-08-23

Countries

  • United Kingdom

Study Locations

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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 NCT03140072 on ClinicalTrials.gov