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LAS190792 Dose 1

Phase 1

Chronic Obstructive Pulmonary Disease (COPD) | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Jun 21, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment55

FDA Designations

No designations recorded

Clinical trial landscape

LAS190792 Dose 1 · 1 trial · 2 indications

Phase 1 1
NCT02059434Two-part Pharmacokinetic and Pharmacodynamic Study of LAS190792 in Patients With Asthma and COPDChronic Obstructive Pulmonary Disease (COPD)
COMPLETED55 Analytics
PHASE1COMPLETED
Two-part Pharmacokinetic and Pharmacodynamic Study of LAS190792 in Patients With Asthma and COPD
Chronic Obstructive Pulmonary Disease (COPD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Subjects With ≥1 Treatment-emergent Adverse Event
30 Days

Adverse events (AEs) are any unfavorable and unintended medical occurrence during the subject's participation in the study (including deterioration of a pre-existing medical condition, an abnormal value in a laboratory assessment, an ECG abnormality, a 12-lead 24-hour ECG-Holter abnormality, a blood pressure abnormal value, paradoxal bronchospasm or an abnormal finding in the physical examination) and will be coded using the current Medical Dictionary for Regulatory Activities (MedDRA).

Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second)
Day 2

Trough is defined as the mean of the FEV1 values obtained at 23 hours and at 24 hours after morning investigational product administration.

Secondary Endpoints

Maximum Observed Plasma Concentration (Cmax)
Up to 36 hours after investigational product administration
Time to Maximum Observed Plasma Concentration (Tmax)
Up to 36 hours after investigational product administration
Area Under the Concentration-time Curve From Zero to the Time of the Last Measurable Concentration
Up to 36 hours after investigational product administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LAS190792 Dose 1 (Part 1)EXPERIMENTALSingle dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
LAS190792 Dose 2 (Part 1)EXPERIMENTALSingle dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
LAS190792 Dose 3 (Part 1)EXPERIMENTALSingle dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
LAS190792 Dose 4 (Part 1)EXPERIMENTALSingle dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
LAS190792 Dose 5 (Part 1)EXPERIMENTALSingle dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
LAS190792 Dose 6 (Part 1)EXPERIMENTALSingle dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
Placebo (Part 1)PLACEBO_COMPARATORSingle dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
LAS190792 Dose 1 (Part 2)EXPERIMENTALSingle dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
LAS190792 Dose 2 (Part 2)EXPERIMENTALSingle dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
Tiotropium 18 μgACTIVE_COMPARATORSingle dose, oral inhalation by HandiHaler® single-dose DPI
Indacaterol 150 μgACTIVE_COMPARATORSingle dose, oral inhalation by Breezhaler® single-dose DPI
Placebo (Part 2)PLACEBO_COMPARATORSingle dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)

Interventions

NameTypeDescription
LAS190792 Dose 1DRUG -
LAS190792 Dose 2DRUG -
LAS190792 Dose 3DRUG -
LAS190792 Dose 4DRUG -
LAS190792 Dose 5DRUG -
LAS190792 Dose 6DRUG -
LAS190792 Dose 1 (Part 2)DRUG -
LAS190792 Dose 2 (Part 2)DRUG -
Tiotropium 18 μgDRUG -
Indacaterol 150 μgDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria (PART 1): * Adult male subjects aged 18 to 70 years * Body mass index (BMI) 18.5 to 30 kg/m2 at screening * Clinical diagnosis of mild persistent asthma (according to GINA guidelines) for at least 6 months prior to screening * Ability to change current asthma therapy, to disconti...

Countries:United Kingdom
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Frequently asked questions about LAS190792 Dose 1

What is LAS190792 Dose 1 used for?

LAS190792 Dose 1 is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes LAS190792 Dose 1?

LAS190792 Dose 1 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is in Phase 1 clinical development for the treatment of COPD.

What phase is LAS190792 Dose 1 in?

LAS190792 Dose 1 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for commercial use. The drug is being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD).

What clinical trials is LAS190792 Dose 1 in?

LAS190792 Dose 1 has been studied in one completed Phase 1 clinical trial with the identifier NCT02059434. This trial was a two-part pharmacokinetic and pharmacodynamic study in patients with asthma and COPD, conducted in the United Kingdom with 55 participants.

Is LAS190792 Dose 1 the same as LAS190792?

LAS190792 Dose 1 is a specific dose of the drug LAS190792. The clinical trial NCT02059434 studied LAS190792 in patients with asthma and COPD, and the dose is being evaluated for its safety and pharmacological effects in these conditions.