Effect of Riocigaut on Cerebral Vasodilation and Headache Induction in Healthy Volunteers

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: 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/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Danish Headache Center
• Treatments: Riociguat

Criteria

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