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Completed

NCT Number: NCT01069822

A Study in Healthy Volunteers to Assess Effect of AZD6765 on Midazolam Blood Levels

The main purpose of this study is to evaluate the effect repeated doses of AZD6765 (a drug being developed for the treatment of patients with severe major depressive disorder) has on the PK (pharmacokinetic) profile of Midazolam. (The PK profile is how the drug leaves your body and acts in the body.)

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Overland Park, Kansas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI between 19-30

Exclusion criteria

  • Significant result for C-SSRS at screening or baseline
  • Single arm preference for IV procedures

Treatment and study plan

AZD6765

Drug

IV solution

midazolam

Drug

Primary outcomes

  1. Pharmacokinetic parameters to be calculated from midazolam and AZD6765 plasma concentrations

    Time frame: on Day -1 and Day 6

Secondary outcomes

  1. Safety variables (adverse events, vital signs, physical and neurological examinations, clinical laboratory assessments, 12-lead ECG, C-SSRS, CADSS, and VAS scales)

    Time frame: will be collected from the time of informed consent (Visit 1) until completion of the follow-up visit.

  2. Optional Genetic sampling

    Time frame: at admission Day -2

  3. Exploratory - renal biomarkers in urine

    Time frame: At admission Day -2 until follow up visit

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I Open-label, Fixed Sequence Study to Determine the Effect of Multiple Intravenous Doses of AZD6765 on the Pharmacokinetics of Oral Midazolam (CYP3A4 Substrate) in Healthy Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 17, 2010
Registry last updated
Oct 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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