A phase 1, single centre, single dose, double-blind, double-dummy, four-way crossover, placebo-controlled, randomized study to investigate the effects of AZD7325 on sedation, cognition and EEG in comparison with lorazepam in healthy male volunteers.

A phase 1, single centre, single dose, double-blind, double-dummy, four-way crossover, placebo-controlled, randomized study to investigate the effects of AZD7325 on sedation, cognition and EEG in comparison with lorazepam in healthy male volunteers. - Effects of AZD7325 on sedation, cognition and EEG.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON32334

Enrollment

Registered

2008-05-08

Start date

2008-06-02

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anxiety anxiety disorders

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Provision of written informed consent 2. Healthy male subjects aged 18 to 55 years (extremes inclusive) on sceening 3. Body Mass Index (BMI) >= 18 and

Exclusion criteria

Exclusion criteria: 1. Clinically relevant disease and/or abnormalities (past or present) which in the opinion of the investigator, may either put the subject at risk to participate in the study or may influence the results of the study or the subject*s ability to participate in the study 2. Psychiatric, medical, and surgical history that may interfere with the objectives of the study 3. Subject*s partner is planning pregnancy within 3 months of last dosing 4. Significant illness, as judged by the investigator, within 2 weeks of the first study day 5. Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, thyroid function test, hematology or urinalysis at screening as judged by the investigator and/or sponsor 6. ECG with a QTcF interval of >450 or

Design outcomes

Primary

Measure	Time frame
To investigate the pharmacodynamic (PD) effects of single oral doses of AZD7325 on sedation and cognition in comparison with lorazepam, a widely used non-selective GABA-A modulator for anxiolysis.	—

Secondary

Measure	Time frame
1. To evaluate the safety and tolerability of AZD7325 by assessing adverse events, vital signs, laboratory parameters, and ECGs. 2. To measure the effects of single oral doses of AZD7325 with electroencephalogram (EEG) and to assess whether the EEG power spectral changes of AZD7325 seen in animal studies are observed in humans. 3. To determine the effects of single oral doses of AZD7325 on body sway and to compare its effects to those of lorazepam. 4. To investigate the pharmacokinetic (PK) profile of AZD7325 after single oral doses administration. Mathematical PK/PD modelling to correlate the relationships between plasma concentration and effects for changes in CNS measurements will be attempted.	—

Measure

Time frame

1. To evaluate the safety and tolerability of AZD7325 by assessing adverse events, vital signs, laboratory parameters, and ECGs. 2. To measure the effects of single oral doses of AZD7325 with electroencephalogram (EEG) and to assess whether the EEG power spectral changes of AZD7325 seen in animal studies are observed in humans. 3. To determine the effects of single oral doses of AZD7325 on body sway and to compare its effects to those of lorazepam. 4. To investigate the pharmacokinetic (PK) profile of AZD7325 after single oral doses administration. Mathematical PK/PD modelling to correlate the relationships between plasma concentration and effects for changes in CNS measurements will be attempted.

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Countries

Netherlands

Outcome results