NCT02140320

Brief Summary

RV1729 is a new medicine being developed for the potential treatment of asthma and smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD). The objective of this study is to investigate the safety, tolerability and pharmacokinetics of single doses of RV1729 and repeat doses of RV1729 for up to 28 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P50-P75 for phase_1 asthma

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

May 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

May 14, 2014

Last Update Submit

April 13, 2015

Conditions

AsthmaHealthy Volunteers

Outcome Measures

Primary Outcomes (5)

  • Incidence of treatment emergent adverse events

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

    Cohort 1, 56 days: Cohorts 2 & 3, 70 days: Cohort 4, 84 days

  • ECG assessment (12-lead ECG)

    Change from pre-dose values

    Cohort 1, 29 days: Cohorts 2 & 3, 42 days: Cohort 4, 56 days

  • Vital sign assessment (blood pressure and heart rate, measured together)

    Change from pre-dose values

    Cohort 1, 29 days: Cohorts 2 & 3, 42 days: Cohort 4, 56 days

  • Clinical laboratory assessments (blood and urine samples, collected together)

    Change from pre-dose values

    Cohort 1, 29 days: Cohorts 2 & 3, 42 days: Cohort 4, 56 days

  • Spirometry assessment (FEV1 & FVC)

    Change from pre-dose values

    Cohort 1, 29 days: Cohorts 2 & 3, 42 days: Cohort 4, 56 days

Secondary Outcomes (1)

  • Plasma RV1729 levels

    Cohort 1: Day 1, 7 samples, Day 2-29, 5 samples; Cohorts 2 & 3: Days 1, 7 & 14, 8 samples, Days 2 & 8-13, 1 sample per day, Days 15-42, 6 samples; Cohort 4: Days 1, 14 & 28, 8 samples, Days 2, 7, 15, 21, 26 & 27, 1 sample per day, Days 29-70, 7 samples;

Other Outcomes (4)

  • Serum biomarkers (measuring markers of inflammation in the blood)

    Cohort 2: Days 1 & 14, 2 samples per day, Days 2, 7, 15 & 42, 1 sample per day; Cohort 3: Days 1 & 14, 2 samples per day, Days 2, 7, 15, 21 & 42, 1 sample per day; Cohort 4: Days 1 & 14, 2 samples per day, Days 7, 21, 29 & 56, 1 sample per day;

  • Exhaled nitric oxide (measuring airway inflammation)

    Cohort 3: Days 1 & 4 - 1 sample, Day 14 - 2 samples

  • Exhaled breath condensate (measuring markers of oxidate stress)

    Cohort 3: Days 1 & 14 - 2 samples per day, Days 17 to 42 - 4 samples

  • +1 more other outcomes

Study Arms (4)

Single dose (healthy volunteers)

EXPERIMENTAL
Drug: RV1729 single doseDrug: RV1729 matching placebo single dose

14 day repeat dose (healthy volunteers)

EXPERIMENTAL
Drug: RV1729 14 day repeat doseDrug: RV1729 matching placebo 14 day repeat dose

14 day repeat dose (asthma patients)

EXPERIMENTAL
Drug: RV1729 14 day repeat doseDrug: RV1729 matching placebo 14 day repeat dose

28 day repeat dose (healthy volunteers)

EXPERIMENTAL
Drug: RV1729 28 day repeat doseDrug: RV1729 matching placebo 28 day repeat dose

Interventions

RV1729 matching placebo 14 day repeat doseDRUG

Safety and tolerability of repeat doses

14 day repeat dose (asthma patients)14 day repeat dose (healthy volunteers)
RV1729 single doseDRUG

Safety and tolerability of single dose

Single dose (healthy volunteers)
RV1729 matching placebo single doseDRUG

Safety and tolerability of single dose

Single dose (healthy volunteers)
RV1729 14 day repeat doseDRUG

Safety and tolerability of repeat doses

14 day repeat dose (asthma patients)14 day repeat dose (healthy volunteers)
RV1729 28 day repeat doseDRUG

Safety and tolerability of repeat doses

28 day repeat dose (healthy volunteers)
RV1729 matching placebo 28 day repeat doseDRUG

Safety and tolerability of repeat doses

28 day repeat dose (healthy volunteers)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be a man or woman between 18 to 60 years of age, inclusive, at the time of signing the informed consent.
  • Cohorts 1, 2 \& 3 women of childbearing potential must have a documented menstrual period prior to the first dose and be willing to use 2 forms of appropriate methods of contraception from screening until 4 months after the final dose of RV1729, OR
  • Women of non-childbearing potential must be spontaneously amenorrhoeic for at least 1 year or have been permanently sterilised, OR
  • If a man, must be willing and able to use one of the contraception methods listed in the protocol and agree not to donate sperm from screening until 4 months after the final dose of RV1729
  • Women must agree not to donate eggs (ova, oocytes) from screening until at least 6 months after the final dose of RV1729
  • Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
  • Body mass index between 19 and 30 kg/m2 and body weight not less than 50 kg.
  • Vital sign assessments within normal ranges
  • Have a 12-lead ECG recording consistent with normal cardiac function
  • Capable of complying with all study restrictions and procedures including ability to use the study inhaler correctly
  • Cohorts 1, 2 \& 4 (healthy volunteers only)
  • Healthy as determined by a physician, based on a full medical evaluation including medical history, physical examination and laboratory tests.
  • Pre-bronchodilator spirometry readings (FEV1 and FVC) to be ≥80% predicted value and FEV1/FVC ratio \>0.7
  • Not taking prescription medications for 14 days prior to screening and agree not to use prescription medications throughout the duration of the study (with the exception of the use of contraceptives or hormone replacement therapy).
  • Not taking over-the-counter medications and herbal medication for 14 days prior to screening throughout the study.
  • +8 more criteria

You may not qualify if:

  • Upper or lower respiratory tract infection within 4 weeks before screening
  • Clinically significant abnormal values for haematology, clinical chemistry or urinalysis at screening or Day -1
  • Has a history of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.
  • History of, or a reason to believe a subject has a history of drug or alcohol abuse within the past 5 years.
  • Positive test for alcohol or drugs of abuse, including cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines or barbiturates at screening or on Day -1
  • History of clinically significant allergies that, in the opinion of the Investigator or Medical Monitor, would contraindicate their participation.
  • Subjects known to suffer from hayfever, or other allergy, that may require antihistamine therapy during the course of the study.
  • Known allergy to the study drug or any of the excipients of the formulation or has previously been exposed to RV1729.
  • Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months or intention to donate blood or blood products during the study.
  • Received an experimental drug or used an experimental medical device within 3 months or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled.
  • If a woman has a positive serum pregnancy test at screening or a positive urine pregnancy test on Day -1, is pregnant, breast-feeding or planning to become pregnant during the study.
  • Liver function test results \>1.5 x ULN (upper limit of normal) at Screening or on Day -1.
  • Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B virus (HBV) infection or hepatitis C antibodies.
  • History of smoking or use of nicotine-containing substances within the previous 6 months, or a positive carbon monoxide test at screening or on Day -1 (or a smoking history ≥ 10 pack years).
  • Preplanned surgery or procedures that would interfere with the conduct of the study.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

London, NW10 7EW, United Kingdom

Location

Unknown Facility

Manchester, M23 9QZ, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Interventions

6-(2-((4-amino-3-(3-hydroxyphenyl)-1H-pyrazolo(3,4-d)pyrimidin-1-yl)methyl)-3-(2-chlorobenzyl)-4-oxo-3,4-dihydroquinazolin-5-yl)-N,N-bis(2-methoxyethyl)hex-5-ynamide

Condition Hierarchy (Ancestors)

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

Study Officials

  • Liza O'Dowd, MD

    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

May 14, 2014

First Posted

May 16, 2014

Study Start

July 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations

GB(2)