The Effect of Intravenous L-kynurenine (LKYN) on Cerebral Hemodynamics in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-01-20

Brief Summary

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To measure the cerebral hemodynamic effect of L-kynurenine.

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Detailed Description

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Aim: To investigate the physiological effect of L-Kynurenine after intravenous administration to healthy volunteers.

Hypothesis: L-kynurenine induces vasodilation in the cerebral vessels and trigger headache in healthy individuals.

Methods: 6 healthy volunteers will receive intravenous infusion of L-kynurenine using the following doses 50 microgram/kg, 100 microgram/kg, 150 microgram/kg, 300 microgram/kg, 500 microgram/kg, 1 mg/kg and 5 mg/kg over 20 min on 7 different days with at least 1 day in between. Before and after infusion (at 20, 40, 60, 80 and 100 min) we will record vital signs, circumferences of middle cerebral artery, superficial temporalis artery and headache intensity and characteristics.

The subjects will then have a questionnaire about headache for the following 24 hours.

Conditions

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Headache

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Pilot, Open label

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Interventions

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L-kynurenine

intravenous infusion of L-kynurenine to healthy individuals.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy volunteers of both sexes.
2. 18-60 years.
3. 50-90 kg.
4. Women of childbearing potential must use adequate contraception.

Exclusion Criteria

1. All primary headaches
2. First-degree relative with migraine
3. Headache less than 48 hours before the tests start
4. Daily consumption of drugs of any kind other than oral contraceptives.
5. Pregnant or nursing women. Cardiovascular disease of any kind, including cerebrovascular diseases.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes