A Phase 1, Single Center, Open-Label Study to Evaluate the Pharmacokinetics, Bioavailability, Dose Proportionality, Safety, and Tolerability of Single Ascending Doses of Dihydroergotamine Mesylate (Zephyr) Inhalation Powder, and Dihydroergotamine Mesylate Intravenous, in Healthy Adult Subjects.

Syneos Health New Zealand Ltd0 sites28 target enrollmentNovember 21, 2023

Overview

No summary available.

Registry

who.int

Start Date

November 21, 2023

End Date

April 19, 2024

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Syneos Health New Zealand Ltd

•1\. Male or female, greater than or equal to 18 and less than or equal to 65 years of age, with BMI \>18\.5 and \<32\.0 kg/m2 at screening.
•2\. Healthy as defined by:
•a. the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
•b. the absence of clinically significant history of neurological, endocrine, cardiovascular,
•pulmonary, hematological (e.g., thrombocytopenia, neutropenia, bleeding disorders),
•immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
•3\. Female subjects of non\-childbearing potential must be at screening:
•a. Post\-menopausal defined as aged more than 50 years and amenorrhea for at least 12 months prior to dosing following cessation of all exogenous hormonal treatments.
•b. Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and having luteinizing hormone (LH) and follicle\-stimulating hormone (FSH) levels in the
•post\-menopausal range for the institution.

•1\. Positive pregnancy test or lactating female subjects at screening or prior to dosing.
•2\. Significant history or clinical manifestation of any metabolic, allergic, dermatological,
•immunological, renal, hepatic, hematological, pulmonary, cardiovascular, gastrointestinal,
•neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator.
•3\. History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study at screening. This includes subjects with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or subjects who have clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal’s variant angina.
•4\. Subject with abnormal lung function defined by spirometry testing such: FEV1 \< 80% of
•predicted normal value OR FEV1/FVC ratio \< 0\.70 at screening.
•5\. History or current diagnosis of COPD, asthma, including childhood asthma, or bronchospasm at screening.
•6\. History of COVID\-19 with unresolved respiratory symptoms and/or unresolved respiratory
•findings, or any previous hospitalization due to COVID\-19\.