Status:
RECRUITING
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers
Lead Sponsor:
Mannkind Corporation
Conditions:
Healthy Volunteers
Eligibility:
All Genders
40-65 years
Phase:
PHASE1
Brief Summary
MKC-NI-001 is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (MNKD-201) in healthy adult volunteers. The trial consists of a Single Ascen...
Eligibility Criteria
Inclusion
- Key
- Is ≥40 and ≤65 years of age at the time of signing the informed consent form.
- Has a negative urine test for selected drugs of abuse and negative alcohol test at screening and upon admission to the CRU on Day -1. Note: Participants should not consume poppy seeds within 24 hours before urine drug screening because this can falsify the results of the opiate urine drug test.
- Is willing to adhere to the restrictions and requirements specified in the protocol.
- Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test (i.e., the virus that causes COVID-19) on Day -1.
- Is capable of performing spirometry, as required by the study procedures.
- Key
Exclusion
- Has a history of significant lung disease (e.g., pulmonary fibrosis, cystic fibrosis, COPD, emphysema, chronic pulmonary infection, recent upper or lower respiratory tract infection in the prior 8 weeks, history of lung surgery or procedure, etc.)
- Has endocrine, thyroid, or respiratory disease, diabetes mellitus, coronary heart disease, GI disease, or history of any psychotic mental illness.
- Has a history of hepatic disease or has abnormal liver function tests (i.e., aspartate aminotransferase \[AST\] \> 1.5 × upper limit of normal \[ULN\] or alanine aminotransferase \[ALT\] \> 1.5 × ULN) at screening.
- Has renal impairment (estimated glomerular filtration rate \[eGFR\] \< 60 mL/min/1.73 m2), as calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), at screening.
- Has any history of pulmonary malignancy.
- Has a history of substance abuse or dependency or history of recreational drug use over the last 2 years (by self-declaration).
Key Trial Info
Start Date :
May 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06532942
Start Date
May 28 2024
End Date
October 31 2024
Last Update
August 6 2024
Active Locations (1)
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1
Flourish Research
San Antonio, Texas, United States, 78229