[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557040":3},{"organization":4,"outcomesModule":7,"designInfo":93,"detailedDescription":92,"studyPopulation":92,"armGroups":105,"interventions":123,"overallOfficials":92,"centralContacts":136,"locations":144,"responsibleParty":168,"collaborators":92,"id":170,"slug":92,"hasResults":171,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":92,"eligibilityCriteria":175,"healthyVolunteers":176,"sex":177,"minAge":178,"maxAge":179,"enrollmentInfo":180,"targetDuration":92,"studyType":183,"phases":184,"briefSummary":186,"conditions":187,"keywords":92,"overallStatus":147,"whyStopped":92,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},{"fullName":5,"class":6},"Mannkind Corporation","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":51,"otherOutcomes":92},[9,13,16,19,21,24,26,29,31,34,36,39,41,44,46,49],{"measure":10,"description":11,"timeFrame":12},"(Part A) Incidence of inhaled intolerability","Incidence of inhaled intolerability (prevalence of cough, dyspnea, bronchospasm, and dysgeusia)","Up to Day 9 (+\u002F- 3 days)",{"measure":14,"description":11,"timeFrame":15},"(Part B) Incidence of inhaled intolerability","Up to Day 15 (+\u002F- 3 days)",{"measure":17,"description":18,"timeFrame":12},"(Part A) Incidence of participants with reductions in FEV1 ≥ 15% from baseline at any time postdose","Incidence of participants with reductions in FEV1 ≥ 15% from baseline at any time postdose",{"measure":20,"description":18,"timeFrame":15},"(Part B) Incidence of participants with reductions in FEV1 ≥ 15% from baseline at any time postdose",{"measure":22,"description":23,"timeFrame":12},"(Part A) Incidence of participants with reductions in FEV1 ≥ 15% following administration of a dose of study drug, compared to the corresponding predose measurement","Incidence of participants with reductions in FEV1 ≥ 15% following administration of a dose of study drug, compared to the corresponding predose measurement",{"measure":25,"description":23,"timeFrame":15},"(Part B) Incidence of participants with reductions in FEV1 ≥ 15% following administration of a dose of study drug, compared to the corresponding predose measurement",{"measure":27,"description":28,"timeFrame":12},"(Part A) Incidence of treatment-emergent adverse events (TEAEs)","Incidence, severity, duration, relationship to study drug, and outcome of treatment-emergent adverse events (TEAEs)",{"measure":30,"description":28,"timeFrame":15},"(Part B) Incidence of treatment-emergent adverse events (TEAEs)",{"measure":32,"description":33,"timeFrame":12},"(Part A) Incidence of serious adverse events (SAEs)","Incidence, severity, duration, relationship to study drug, and outcome of serious adverse events (SAEs)",{"measure":35,"description":33,"timeFrame":15},"(Part B) Incidence of serious adverse events (SAEs)",{"measure":37,"description":38,"timeFrame":12},"(Part A) Incidence of abnormal clinically significant vital signs","Incidence of abnormal clinically significant vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation rate, and body temperature)",{"measure":40,"description":38,"timeFrame":15},"(Part B) Incidence of abnormal clinically significant vital signs",{"measure":42,"description":43,"timeFrame":12},"(Part A) Changes from baseline in liver enzymes and bilirubin","Changes from baseline in liver enzymes and bilirubin",{"measure":45,"description":43,"timeFrame":15},"(Part B) Changes from baseline in liver enzymes and bilirubin",{"measure":47,"description":48,"timeFrame":12},"(Part A) Changes from baseline in coagulation parameters, INR and aPTT","Changes from baseline in coagulation parameters - international normalized ratio (INR) and activated partial thromboplastin time (aPTT)",{"measure":50,"description":48,"timeFrame":15},"(Part B) Changes from baseline in coagulation parameters, INR and aPTT",[52,55,58,60,62,64,66,68,69,71,73,75,77,79,81,83,85,89],{"measure":53,"description":53,"timeFrame":54},"(Part A) Maximum plasma MNKD-201 concentration (Cmax)","Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose",{"measure":56,"description":56,"timeFrame":57},"(Part B) Maximum plasma MNKD-201 concentration (Cmax)","Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7",{"measure":59,"description":59,"timeFrame":54},"(Part A) Time to maximum concentration (Tmax)",{"measure":61,"description":61,"timeFrame":57},"(Part B) Time to maximum concentration (Tmax)",{"measure":63,"description":63,"timeFrame":54},"(Part A) Terminal elimination half-life (t½)",{"measure":65,"description":65,"timeFrame":57},"(Part B) Terminal elimination half-life (t½)",{"measure":67,"description":67,"timeFrame":54},"(Part A) Area under the plasma concentration-time curve (AUC) from time zero (from the start of inhalation time) to the last measurable concentration (AUC0-t)",{"measure":67,"description":67,"timeFrame":57},{"measure":70,"description":70,"timeFrame":54},"(Part A) AUC from time zero (time of first inhalation) to infinity (AUC0-∞)",{"measure":72,"description":72,"timeFrame":57},"(Part B) AUC from time zero (time of first inhalation) to infinity (AUC0-∞)",{"measure":74,"description":74,"timeFrame":54},"(Part A) Apparent terminal elimination rate constant (Kel)",{"measure":76,"description":76,"timeFrame":57},"(Part B) Apparent terminal elimination rate constant (Kel)",{"measure":78,"description":78,"timeFrame":54},"(Part A) Apparent total body clearance (CL\u002FF)",{"measure":80,"description":80,"timeFrame":57},"(Part B) Apparent total body clearance (CL\u002FF)",{"measure":82,"description":82,"timeFrame":54},"(Part A) Apparent volume of distribution during the terminal phase (Vz\u002FF)",{"measure":84,"description":84,"timeFrame":57},"(Part B) Apparent volume of distribution during the terminal phase (Vz\u002FF)",{"measure":86,"description":87,"timeFrame":88},"(Part A) Changes in forced expiratory volume in 1 second (FEV1) before and after dosing","(Part A) Changes in forced expiratory volume in 1 second (FEV1) before and after dosing (predose and 5, 15, 30, 60, 90, and 120 minutes postdose)","predose and 5, 15, 30, 60, 90, and 120 minutes postdose",{"measure":90,"description":91,"timeFrame":88},"(Part B) Changes in forced expiratory volume in 1 second (FEV1) before and after dosing","(Part B) Changes in forced expiratory volume in 1 second (FEV1) before and after dosing (predose and 5, 15, 30, 60, 90, and 120 minutes postdose)",null,{"allocation":94,"interventionModel":95,"interventionModelDescription":96,"primaryPurpose":97,"observationalModel":92,"timePerspective":92,"maskingInfo":98},"RANDOMIZED","PARALLEL","This first-in-human trial will be conducted in healthy adult volunteers and will investigate the safety, tolerability, and PK of MNKD-201. MNKD-201 will be evaluated over a range of doses, first in a SAD phase (Part A) and then in a MAD phase (Part B), to inform doses for further evaluation in a subsequent trial. Approximately 40 participants will be enrolled into 1 of 3 SAD cohorts and 2 MAD cohorts, 8 participants per cohort.","TREATMENT",{"masking":99,"maskingDescription":92,"whoMasked":100},"QUADRUPLE",[101,102,103,104],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[106,112,117],{"label":107,"type":108,"description":109,"interventionNames":110},"(Part A) MKND-201 SAD","EXPERIMENTAL","Part A involves a Single Ascending Dose (SAD) study with three cohorts. In each cohort, participants will receive a single dose of MKND-201 or placebo for one day. The doses will be categorized as Target Dose, High Dose, and Very High Dose. Allocation is randomized and double-blind, maintaining a ratio of 3:1 (MKND-201:placebo). Participants will use a breath-powered inhaler, which aerosolizes the powder for lung delivery",[111],"Drug: (Part A) MKND-201",{"label":113,"type":108,"description":114,"interventionNames":115},"(Part B) MKND-201 MAD","Part B involves a Multiple Ascending Dose (MAD) study with two cohorts. In each cohort, participants will receive MKND-201 or placebo twice daily (BID) at either the Target Dose or High Dose. Allocation is randomized 3:1 (MKND-201:placebo) and double-blind. Participants will use a breath-powered inhaler, which aerosolizes the powder for lung delivery",[116],"Drug: (Part B) MKND-201",{"label":118,"type":119,"description":120,"interventionNames":121},"Placebo","PLACEBO_COMPARATOR","Administered as a single dose or BID using the same number of cartridges as MKND-201 participants in the same cohort",[122],"Drug: Placebo",[124,129,132],{"type":125,"name":126,"description":127,"armGroupLabels":128,"otherNames":92},"DRUG","(Part A) MKND-201","Participants will receive single ascending doses (Target Dose, High Dose, and Very High Dose) of MKND-201 or placebo administered via oral inhalation on Day 1",[107],{"type":125,"name":118,"description":130,"armGroupLabels":131,"otherNames":92},"Participants will receive matching placebo across Part A and Part B of the study.",[118],{"type":125,"name":133,"description":134,"armGroupLabels":135,"otherNames":92},"(Part B) MKND-201","Participants will receive multiple ascending doses (Target Dose and High Dose) of MKND-201 or placebo administered via oral inhalation, twice daily, from Day 1 to Day 7",[113],[137,142],{"name":138,"role":139,"phone":140,"phoneExt":92,"email":141},"Jennifer Pleitez","CONTACT","818-661-5000","MKC-NI-001study@mannkindcorp.com",{"name":143,"role":139,"phone":140,"phoneExt":92,"email":141},"Johanna Ulloa",[145],{"facility":146,"status":147,"city":148,"state":149,"zip":150,"country":151,"countryCode":152,"cosmosGeoPoint":153,"geoPoint":158,"contacts":159},"Flourish Research","RECRUITING","San Antonio","Texas","78229","United States","US",{"type":154,"coordinates":155},"Point",[156,157],-98.49363,29.42412,{"lat":157,"lon":156},[160,165],{"name":161,"role":139,"phone":162,"phoneExt":163,"email":164},"Sierra Wilson","210-949-0122","208","SWilson@flourishresearch.com",{"name":166,"role":167,"phone":92,"phoneExt":92,"email":92},"Douglas Denham, DO","PRINCIPAL_INVESTIGATOR",{"type":169,"investigatorFullName":92,"investigatorTitle":92,"investigatorAffiliation":92,"oldNameTitle":92,"oldOrganization":92},"SPONSOR","100557040",false,"NCT06532942","A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Nintedanib Inhalation Powder (MNKD-201) in Healthy Volunteers","Key Inclusion Criteria:\n\n* Is ≥40 and ≤65 years of age at the time of signing the informed consent form.\n* 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.\n* Is willing to adhere to the restrictions and requirements specified in the protocol.\n* Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test (i.e., the virus that causes COVID-19) on Day -1.\n* Is capable of performing spirometry, as required by the study procedures.\n\nKey Exclusion Criteria:\n\n* 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.)\n* Has endocrine, thyroid, or respiratory disease, diabetes mellitus, coronary heart disease, GI disease, or history of any psychotic mental illness.\n* 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.\n* Has renal impairment (estimated glomerular filtration rate \\[eGFR\\] \\\u003C 60 mL\u002Fmin\u002F1.73 m2), as calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), at screening.\n* Has any history of pulmonary malignancy.\n* Has a history of substance abuse or dependency or history of recreational drug use over the last 2 years (by self-declaration).",true,"ALL","40 Years","65 Years",{"count":181,"type":182},40,"ESTIMATED","INTERVENTIONAL",[185],"PHASE1","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 Ascending Dose (SAD), followed by a Multiple Ascending Dose (MAD) with a primary objective to evaluate the safety, tolerability, and pharmacokinetics (PK) of MNKD-201 compared to placebo in healthy adult participants.",[188],"Healthy Volunteers","2024-08-02",{"date":191,"type":192},"2024-08-06","ACTUAL",{"date":194,"type":192},"2024-05-28",{"date":196,"type":182},"2024-10-31",{"name":5,"class":6},1]