Overview
Effect of Riocigaut on Cerebral Vasodilation and Headache Induction in Healthy Volunteers
Status:
Recruiting
Recruiting
Trial end date:
2024-01-01
2024-01-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This double-blind, randomized, placebo-controlled cross-over clinical trial aims to investigate the effects of riocigaut on cerebral arteries and headache inducing properties in healthy volunteers.Phase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Danish Headache CenterTreatments:
RiociguatCriteria
Inclusion Criteria:- Ability to provide written informed consent and receive participant privacy and rights
information.
- Male or female participants aged 18-45 years.
- Weight between 50-100kg
- Non-smokers
Exclusion Criteria:
- Any current or previous known primary or secondary headache disorder(s) apart from
tension type headache ≤ 1 day per month.
- Headache <48 hours before study start.
- Daily use of any medication except contraceptives. Specifically use of nitrates or
nitric oxide donors or phosphodiesterase inhibitors.
- Intake of any pro necessitate medication later than 4 times plasma half-life for the
specific drug before study start, except for contraceptives
- Women of child-bearing potential not currently using safe contraceptives. Women of
child-bearing potential does not include hysterectomized women and women who have been
in menopause for at least 2 years. Safe contraceptives include either IUD, birth
control pills, surgical sterilization of the woman, depositary gestagen, barrier
prevention or sexual abstinence.
- Pregnant or breastfeeding women
- Positive pregnancy urin screening on screening day or study days.
- A medical history or clinical signs of
- Hypertension (systolic blood pressure >140mmHg and/or diastolic blood pressure
>90mmHg)
- Hypotension (systolic blood pressure <100mmHg and/or diastolic blood pressure
<50mmHg)
- Electrocardiogram (ECG) with any clinically significant abnormalities at screening
determined by the investigator, including but not limited to, prolonged PQ or QTc
interval, signs of arrythmias, ischemia or left/right ventricle
dysfunction/hypertrophy.
- Blood work at screening with signs of anemia.
- Blood work at screening with signs of abnormal kidney and liver function.
- A medical history or clinical signs of cardiovascular disease including
cerebrovascular disease.
- A medical history or clinical signs of pulmonary disease.
- A medical history or clinical signs of liver, renal, gastrointestinal, endocrine,
hematological or neurological disease.
- A medical history or clinical signs of psychiatric illness or substance abuse
- A medical history or clinical signs of drug or alcohol abuse
- A medical history or clinical signs of disease of any origin that the investigative
doctor finds relevant for participation in the study
- A family history of severe cardiac disease.
- Any history of hypersensitivity to riociguat.
- Subjects who do not want information about crucial pathological findings during the
study