NCT02517359

Brief Summary

RV6153 is a new medicine being developed for possible treatment of asthma and smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD). The main purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of RV6153

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1 asthma

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 4, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

July 28, 2015

Last Update Submit

March 3, 2016

Conditions

AsthmaHealthy Volunteers

Outcome Measures

Primary Outcomes (8)

  • Safety and tolerability of single and repeat doses assessed by incidence of treatment emergent adverse events

    Assessment of the number of adverse events reported by subjects following dosing

    Up to 29 days post final dose

  • Safety and tolerability of single and repeat doses assessed by ECG (12-lead ECG)

    12-lead ECGs will be obtained using an ECG machine that automatically calculates heart rate and measures PR, QRS, QT, and QTcB/QTcF intervals. ECGs will be measured after resting for 5 minutes

    Up to 29 days post final dose

  • Safety and tolerability of single and repeat doses assessed by vital sign measurement (blood pressure & heart rate)

    Blood pressure heart rate will be assessed together using an automated device after resting for 5 minutes. Blood pressure will include systolic and diastolic measurements.

    Up to 29 days post final dose

  • Safety and tolerability of single and repeat doses assessed by respiration rate

    Respiration rate will be measured after resting for 5 minutes

    Up to 29 days post final dose

  • Safety and tolerability of single and repeat doses assessed by temperature

    Temperature will be measured orally

    Up to 29 days post final dose

  • Safety and tolerability of single and repeat doses assessed by spirometry

    Pulmonary function test measured from forced expiratory volume in 1 second (FEV1). Pulmonary function test will be repeated until three technically acceptable measurements have been made.

    Up to 29 days post final dose

  • Safety and tolerability of single and repeat doses by assessment of clinical laboratory tests

    Clinical laboratory tests include haematology, clinical chemistry, urinalysis and additional parameters

    Up to 29 days post final dose

  • Pharmacodynamic (PD) effect of repeat doses of RV6153 assessed by sputum cell biomarkers

    Sputum samples will be collected to evaluate PD effects of repeat doses of RV6153 by assessment of phosphatidylinositol biphosphate (PIP2) and phosphatidylinositol triphosphate (PIP3).

    Cohort 13 (subjects who smoke) only - assessments at screening and Days 1, 7 & 14

Secondary Outcomes (1)

  • Plasma RV6153 levels

    Cohorts 1-9: Day 1, 10 samples, Days 2,8,15&29, 1 sample per day; Cohorts 10, 12 & 13: Days 1,7&14, 10 samples per day, Days 2,8-13,1,21,28&42, 1 sample per day; Cohort 11: Days 1,14&28, 10 samples per day, Days 7,21,26,27,29,35,42&56, 1 sample per day

Other Outcomes (1)

  • Sputum markers of inflammation

    Cohort 13 (subjects who smoke) only - assessments at screening and Days 1, 7 & 14

Study Arms (5)

Single dose, healthy volunteers

EXPERIMENTAL
Drug: RV6153 single doseDrug: RV6153 matching placebo single dose

14 day repeat dose, healthy volunteers

EXPERIMENTAL
Drug: RV6153 14 day repeat doseDrug: RV6153 matching placebo 14 day repeat dose

28 day repeat dose, healthy volunteers

EXPERIMENTAL
Drug: RV6153 28 day repeat doseDrug: RV6153 matching placebo 28 day repeat dose

14 day repeat dose, asthma patients

EXPERIMENTAL
Drug: RV6153 14 day repeat doseDrug: RV6153 matching placebo 14 day repeat dose

14 day repeat dose, smokers

EXPERIMENTAL
Drug: RV6153 14 day repeat doseDrug: RV6153 matching placebo 14 day repeat dose

Interventions

RV6153 single doseDRUG

Safety and tolerability of single doses

Single dose, healthy volunteers
RV6153 matching placebo single doseDRUG

Safety and tolerability of single doses

Single dose, healthy volunteers
RV6153 14 day repeat doseDRUG

Safety and tolerability of repeat doses

14 day repeat dose, asthma patients14 day repeat dose, healthy volunteers14 day repeat dose, smokers
RV6153 matching placebo 14 day repeat doseDRUG

Safety and tolerability of repeat doses

14 day repeat dose, asthma patients14 day repeat dose, healthy volunteers14 day repeat dose, smokers
RV6153 28 day repeat doseDRUG

Safety and tolerability of repeat doses

28 day repeat dose, healthy volunteers
RV6153 matching placebo 28 day repeat doseDRUG

Safety and tolerability of repeat doses

28 day repeat dose, healthy volunteers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cohorts 1 to 13 (all subjects)
  • Subject must be a man or woman aged between 18 to 65 years of age, inclusive: Women of non-childbearing potential only - defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile or permanently sterilised. Men who are willing and able to use suitable contraception methods listed in Section 4.5.1, from the time of the first dose of study medication until 90 days after discharge from the study.
  • A woman must have a negative serum β human chorionic gonadotropin (β-hCG) test at screening and a negative urine pregnancy test at Day -1.
  • Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • Each subject must sign an informed consent form (ICF)
  • Body weight ≥50 kg and BMI within the range 19-29 kg/m2 (inclusive).
  • Average QTcF \<450 msec at screening and Day -1 visits
  • Vital sign assessments within normal ranges.
  • Cohorts 1 to 11 and 13 (healthy volunteers and smokers only)
  • Healthy as determined by a physician, based on a full medical evaluation including medical history, physical examination, laboratory tests.
  • Spirometry readings (FEV1 and FVC) to be ≥80% predicted value and FEV1/FVC ratio \>0.7 at screening.
  • Cohort 12 (asthma patients only)
  • Documented history of asthma, first diagnosed at least 6 months prior to the screening visit.
  • Currently being treated with daily standard of care asthma therapy
  • Have a diagnosis of asthma confirmed at screening by bronchodilator reversibility.
  • +5 more criteria

You may not qualify if:

  • Cohorts 1 to 13 (all subjects)
  • Upper or lower respiratory tract infection within 4 weeks of the screening visit and prior to randomisation.
  • A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody result at screening.
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
  • Positive test for alcohol or drugs of abuse.
  • Use of prescription medications within 14 days prior to the screening visit and agree not to use prescription medications throughout the duration of the study.
  • Are taking over the counter (OTC) medications for 14 days prior to Screening visit and agree to refrain from taking such medications throughout the study.
  • History of regular alcohol consumption within 6 months of the study
  • Definite or suspected history of drug or alcohol abuse within the previous 5 years.
  • A positive test for HIV antibody.
  • Received an experimental drug or used an experimental medical device within 3 months or within a period less than five times the drug's half-life before the first dose of the study drug is scheduled.
  • Allergy to any of the active or inactive ingredients (including lactose and milk protein intolerance) in the study medication.
  • History of drug, or other allergy that would contraindicate their participation.
  • A disclosed history or one known to the Investigator, of significant non-compliance in previous investigational studies or with prescribed medications.
  • Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study.
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Manchester, M23 9QZ, United Kingdom

Location

Unknown Facility

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Christopher O'Brien, MD, PhD, FCCP

    Sponsor GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2015

First Posted

August 7, 2015

Study Start

July 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 4, 2016

Record last verified: 2016-03

Locations

GB(2)