An Evaluation of VR942 in Healthy Volunteers and Patients With Mild Asthma

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: VR942 delivered via a Vectura Dry Powder Inhaler; Drug: Placebo delivered via a Vectura Dry Powder Inhaler

• Registration Number: NCT02473939
• Lead Sponsor: Vectura Limited

Brief Summary

The purpose of the study is to Evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of VR942 in healthy subjects (part 1) and repeated doses in mild asthmatics (part 2).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-29
• Study Start: 2015-06
• Study First Submitted QC: 2015-06-12
• Study First Posted: 2015-06-17
• Primary Completion: 2016-04
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-19
• Last Update Posted: 2016-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR942 Dose 1	VR942 delivered via a Vectura Dry Powder Inhaler	VR942 Dose 1
VR942 Dose 1	Placebo delivered via a Vectura Dry Powder Inhaler	VR942 Dose 1
VR942 Dose 3	VR942 delivered via a Vectura Dry Powder Inhaler	VR942 Dose 3
VR942 Dose 2	VR942 delivered via a Vectura Dry Powder Inhaler	VR942 Dose 2
VR942 Dose 4	VR942 delivered via a Vectura Dry Powder Inhaler	VR942 Dose 4
VR942 Dose 2	Placebo delivered via a Vectura Dry Powder Inhaler	VR942 Dose 2
VR942 Dose 5	Placebo delivered via a Vectura Dry Powder Inhaler	VR942 Dose 5
VR942 Dose 3	Placebo delivered via a Vectura Dry Powder Inhaler	VR942 Dose 3
VR942 Dose 4	Placebo delivered via a Vectura Dry Powder Inhaler	VR942 Dose 4
VR942 Dose 5	VR942 delivered via a Vectura Dry Powder Inhaler	VR942 Dose 5

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of the safety and tolerability of single doses of VR942 in healthy subjects and repeated doses of VR942 in mild asthmatics	28 days	o Vital signs, physical examinations, any AEs or adverse device effects, laboratory tests, spirometry, and ECG variables

Secondary Outcome Measures

Name	Time	Method
The pharmacodynamics of repeat doses of VR942 in mild asthmatics	28 days	o Change in biomarker levels
The pharmacokinetic profile of single (Part 1) and repeated doses (part 2) of VR942 (time frame 4 and 14 days for Part 1 & 2 respectively):	4 and 14 days for Part 1 and 2 respectively	Part 1: Cmax, tmax, t½, AUC0-t, AUC0-∞ and Kel; Part 2: Cmax, tmax, and AUC0-τ (post-dose on Day 1) Ctrough on Days 2, 9 and 10 Cmax, tmax, t½, AUC0-t, AUC0-τ, Kel (post-dose on Day 10) Accumulation ratio Racc (Cmax on Day 10/Cmax on Day 1), (AUC0-τ on Day 10/AUC0-τ on Day 1) and (Cmin on Day 10/Cmin on Day 2)
The number of used blisters and inhalers that do not meet the performance characteristics of the device intended by the manufacturer	28 days	o Examination of a sample of used blisters and inhalers will be conducted

Trial Locations

Locations (1)

Vectura Study Site; 🇬🇧 London, United Kingdom