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Pesquisa Study Connect
  • NCT06211179

Recruiting

A Study to Assess the Relative Bioavailability of 5 mg Mavacamten Opened Capsule Administered Via Nasogastric Tube Compared to Intact Oral 5 mg Mavacamten in Healthy Participants - CV027-1070

Atualizado: 29 fevereiro, 2024   |   ClinicalTrials.gov

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Detalhes do estudo

  • Phase 1

    Fase

  • Gênero(s)

  • 18-60

    Faixa etária

  • 1

    Localização(ões)

  • Recruiting

Opções de tratamento

Braços de tratamento do Estudo
INTERVENÇÃO ATRIBUÍDA
Experimental: Sequence ABC
Drug: Treatment A: Mavacamten intact oral capsule, Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT), Treatment B: Mavacamten open capsule in suspension
Experimental: Sequence BCA
Drug: Treatment A: Mavacamten intact oral capsule, Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT), Treatment B: Mavacamten open capsule in suspension
Experimental: Sequence CAB
Drug: Treatment A: Mavacamten intact oral capsule, Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT), Treatment B: Mavacamten open capsule in suspension

Principais critérios de elegibilidade

Inclusion Criteria: - Participants must have a body mass index between 18 and 32 kg/m2. - Participants must be healthy, as determined by physical examination, vital signs, ECGs, and clinical laboratory assessments. - Participants must be willing and able to adhere to the prohibitions and restrictions specified in the protocol. Exclusion Criteria: - Participants must not have any significant acute or chronic medical illness. - Participants must not have any current or recent (within 3 months of study intervention administration) gastrointestinal disease including, but not limited to, bowel obstruction or perforation, gastrointestinal ulcers, esophageal varices, Crohn's disease, diverticulitis, irritable bowel syndrome, ileus, a gastrointestinal tract that is not anatomically intact, dyspepsia, constipation, diarrhea, or vomiting. - Participants must not be intolerant or allergic to lidocaine or cetacaine or any type of topical anesthetic. Other protocol-defined inclusion/exclusion criteria apply

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