Cerebral Pharmacodynamic Effects of 5-HT1B Receptor Stimulation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02932488
• Date of registration: 07/10/2016
• Prospective Registration: No
• Primary sponsor: Gitte Moos Knudsen
• Public title: Cerebral Pharmacodynamic Effects of 5-HT1B Receptor Stimulation
• Scientific title: Cerebral Pharmacodynamic Effects of 5-HT1B Receptor Stimulation
• Date of first enrolment: September 2016
• Target sample size: 17
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02932488
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Denmark

Contacts

• Name: Gitte M Knudsen, MD, DMSc
• Affiliation: Neurobiology Research Unit, Rigshospitalet

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy subjects

- Age 18-60

Exclusion Criteria:

- Primary psychiatric disease (DSM IV Axis I or WHO ICD-10 diagnostic classification).

- Present or former neurological diseases,

- Severe somatic disease

- Medication that can interfere with the test results.

- Doesn't speak Danish fluently or is severely, visually or hearing impaired.

- Information regarding former learning disabilities.

- Pregnancy at the time of the scanning

- Breast feeding

- MR-scanner incompatibility (metal in soft tissue)

- Alcohol or drug abuse

- Allergy to ingredients in used drugs

- Participation in experiments with radioactivity (>10 mSv) within the last year or
considerable work-related exposure to radioactivity.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Drug: Sumatriptan

Primary Outcome(s)

Changes in 5-HT1B receptor binding as measured with [11C]AZ10419369 [Time Frame: Two binding potentials are obtained from the 120 min scan: Baseline BPND is determined from 0-50 min. Intervention BPND is determined from 50-120 min.]

Changes in cerebral blood flow measured with pseudo continuous Arterial Spin Labeling [Time Frame: CBF is measured 15 min prior and 30 min after the injection of sumatriptan giving 45 min of total CBF measurement time.]

Secondary Outcome(s)

Change in [11C]AZ10419369 concentration in blood and plasma [Time Frame: At 2.5, 20, 49, 51, 90 and 120 min after injection of [11C]AZ10419369]

Plasma concentration of sumatriptan [Time Frame: At -1, 1, 10, 20, 35 and 75 min after injection of sumatriptan]

Secondary ID(s)

NP3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors