A5026195231- Migraine and Headache Studies
- Trigeminal Neuralgia and Treatments
- Respiratory and Cough-Related Research
- Cardiac electrophysiology and arrhythmias
- Amyotrophic Lateral Sclerosis Research
- Neuroscience of respiration and sleep
- Psychosomatic Disorders and Their Treatments
- Neurological Complications and Syndromes
- Sympathectomy and Hyperhidrosis Treatments
- Pharmaceutical studies and practices
- Anesthesia and Sedative Agents
- Asthma and respiratory diseases
- Analytical Methods in Pharmaceuticals
Biohaven Pharmaceuticals (United States)
2022-2024
Zavegepant is a novel gepant administered as nasal spray approved in the United States at 10 mg dose for acute treatment of migraine with or without aura adults. The cardiovascular safety zavegepant was assessed both single-ascending (SAD) and multiple-ascending (MAD) studies healthy participants. SAD study included 72 participants (54 active/18 placebo) who received 0.1-40 placebo. MAD (56 active/16 5-40 placebo 1-14 days. Plasma pharmacokinetics electrocardiographic (ECG) parameters...
Abstract Objective To evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) interactions between zavegepant sumatriptan in healthy adults. Background Zavegepant is a high‐affinity, selective, small‐molecule calcitonin gene–related peptide receptor antagonist administered as nasal spray approved United States for acute treatment of migraine. Triptans, including sumatriptan, are different class drugs migraine associated with risk increased blood pressure (BP). Hence, it important to study...
Abstract Zavegepant, a high‐affinity, selective, small‐molecule calcitonin gene‐related peptide (CGRP) receptor antagonist, is approved in the United States for acute treatment of migraine adults. The effects moderate hepatic impairment (8 participants with Child‐Pugh score 7–9 points) on pharmacokinetics single 10‐mg intranasal dose zavegepant versus eight matched normal function were evaluated phase I study. Pharmacokinetic sampling determined total and unbound plasma concentrations....
Abstract Zavegepant, a high‐affinity, selective, small‐molecule calcitonin gene‐related peptide receptor antagonist, is approved as nasal spray for acute treatment of migraine in adults. This phase I, open‐label, single‐center, single‐period, nonrandomized study six healthy male subjects assessed mass balance recovery after single 15‐min intravenous (IV) infusion dose carbon‐14 ([ 14 C])‐zavegepant. Blood, urine, and fecal samples were collected over 192 h analysis zavegepant plasma urine;...
<h3>Objective:</h3> Evaluate co-administration of zavegepant+sumatriptan on resting blood pressure (BP); pharmacokinetics (PK) sumatriptan and zavegepant alone combined; effects BP vs placebo; safety tolerability in healthy participants. <h3>Background:</h3> Zavegepant (BHV-3500; formerly vazegepant) is a high-affinity, selective, small-molecule CGRP receptor antagonist development for migraine. <h3>Design/Methods:</h3> In Phase 1, single-center, randomized, partially blind,...
<h3>Objective:</h3> To report results from the first four regimens of HEALEY ALS Platform Trial. <h3>Background:</h3> The Trial is a perpetual adaptive phase 2/3 multi-regimen trial that allows for shared infrastructure and use placebo data. initial have completed randomized placebo-controlled treatment period. <h3>Design/Methods:</h3> multicenter, randomized, placebo-controlled, multi-arm with randomization ratio 3:1 to active drug or matching interim analyses early futility. A 24-week...