Evaluating the Safety, Tolerability and Effectiveness of ADX-629 t to Treat Chronic Cough

Overview

Información sobre este estudio

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of ADX-629 300 mg administered orally BID for 14 days to approximately 50 adult subjects with refractory or unexplained chronic cough.

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

- Adults ≥18 to ≤80 years of age

- History of refractory or unexplained chronic cough

- Historical Chest radiograph or CT scan that does not demonstrate any abnormality
considered to be significantly contributing to chronic cough

- Not pregnant, breastfeeding, or lactating and agree to use a highly effective method
of acceptable contraceptive for the trial duration, if applicable

- Agree to discontinue antitussive medications for the trial duration

Exclusion Criteria:

- Current smoker (including cannabis products) or previous smoker having recently given
up smoking or has a history of smoking of >20 pack-years

- History of significant cardiovascular disease or any clinically significant
abnormalities in rhythm or conduction

- History or presence of significant hepatic disease or any other condition known to
interfere with absorption, distribution, metabolism, or excretion of drugs.

- History of any malignancy within 5 years of screening except for basal cell or
squamous cell in situ skin carcinomas or carcinoma in situ of the cervix that has been
treated with no evidence of recurrence.

- Recent history of drug or alcohol abuse or a positive urine drug test at screening

- Positive serology test for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or HIV-1
and HIV-2

- Currently taking an angiotensin converting enzyme inhibitor (ACEI) or has used an ACEI
within 3 months of Screening.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 11/23/22. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Vivek Iyer, M.D., M.P.H.

Cerrado para la inscripción

More information

Publicaciones

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CLS-20531876

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