Skip to content

The effect of inhibition of a transporter on sedation after antihistamine administration.

The effect of P-glycoprotein transport inhibition on brain mechanisms of sedation and cognitive impairment following antihistamines in healthy volunteers.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26369
Enrollment
16
Registered
2010-11-15
Start date
2011-01-02
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Healthy subjects, sedation, antihistamines, P-glycoproteintransporter, fMRI, attention. Gezonde proefpersonen, vermoeidheid, antihistamines, P-glycoproteinetransporter, fMRI, aandacht.

Interventions

There are two testdays, with two fMRI scan sessions per testday. The first (randomly assigned) testday consists of the following treatments: Before scan 1: Placebo and 90 minutes later, before scan

Sponsors

Maastricht University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 45 years; 2. Healthy volunteers; 3. BMI between 19 and 30; 4. Able to give a written informed consent; 5. Able to understand the protocol and to come to the visits; 6. Use of a contraceptive method (for women).

Exclusion criteria

Exclusion criteria: 1. Medical history of major medical, psychiatric illness or surgery which, in the judgement of the investigator, could jeopardize their health or is likely to modify their handling of the study drug; 2. Any non corrected visual defect or locomotor disorder which could interfere with the study; 3. Acute or chronic systemic disease or disorder; 4. History of hypersensitivity to H1 antihistamines, benzimidazoles or lactose; 5. Seasonal allergic rhinitis or urticaria treated by antihistamine; 6. History of alcohol or drug abuse.

Design outcomes

Primary

MeasureTime frame
The mean reaction time (ms) of the Attention Network Test (ANT).

Secondary

MeasureTime frame
Cognitive tests: 1. The attention network test; 2. The simple reaction time test; 3. MRI resting state; 4. The BOLD signal.

Contacts

Public ContactSilke Conen

P.O. Box 616

silke.conen@maastrichtuniversity.nl+31 (0)43 3884335

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)