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NCT01121302 · ClinicalTrials.gov registry record · Phase 1

Study to Investigate Single Ascending Oral Doses of AZD5213 in Healthy Male and Non Fertile Female Subjects

A Phase 1 study of Tolerability, sponsored by AstraZeneca.

Completed
Registry status
Phase 1
Development phase
88
Enrollment target
1
Study location

NCT01121302 is a Phase 1 study of Tolerability that has completed, run by AstraZeneca. The registered enrollment target is 88 participants, below the 192-participant average among 4 other Tolerability trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01121302, a Phase 1 study of Tolerability, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 1
Development phase
88 participants
Enrollment target
1
Study location

Study Summary

1. The main purpose of this study is to assess the safety and tolerability of AZD5213 after single oral doses. 2. Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves your body and how your body acts on the study drug) of AZD5213 in your blood and urine. One group of subjects will be studied to see how food affects the pharmacokinetics (PK) of AZD5213 in the blood and urine. They will receive AZD5213 once after fasting overnight and then return to the clinic to receive AZD5213 after eating a high fat breakfast.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG AZD5213

Study Locations (1)

Kansas

  • Research Site - Overland Park

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2010-05
Est. Completion 2010-12
Phase Phase 1

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT01121302

The ClinicalTrials.gov registry entry for NCT01121302 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 192-participant average among 4 other Tolerability trials with a reported enrollment target (54% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Tolerability appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01121302 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.

Frequently Asked Questions

What is clinical trial NCT01121302 about?

NCT01121302 is a clinical study titled "Study to Investigate Single Ascending Oral Doses of AZD5213 in Healthy Male and Non Fertile Female Subjects". 1. The main purpose of this study is to assess the safety and tolerability of AZD5213 after single oral doses. 2. Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves your body and how your body acts on the study drug) of AZD5213 in...

What is the current status of trial NCT01121302?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2010-05. Estimated completion is 2010-12.

What conditions does trial NCT01121302 study?

This clinical trial studies the following conditions: Tolerability.

What interventions are being tested in trial NCT01121302?

The interventions under investigation include: Placebo (DRUG), AZD5213 (DRUG).

Who is sponsoring clinical trial NCT01121302?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01121302 being conducted?

This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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