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Safety, Tolerability and Pharmacokinetics (PK) of RV1162 in Healthy Subjects and COPD Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety, Tolerability and Pharmacokinetics (PK) of RV1162 in Healthy Subjects and COPD Patients

A Randomised, Double Blind, Placebo-controlled, Three Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treatment With Single and Repeat Doses of Inhaled RV1162 in Healthy Subjects and Subjects With Chronic Obstructive Pulmonary Disease.

NCT01970618•Respivert Ltd

View on ClinicalTrials.gov

Summary

RV1162 is a new medicine being developed for possible treatment of smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD). The main purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single and repeat doses of RV1162.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.
•If a woman of childbearing potential, must have a documented menstrual period prior to the first dose and be willing and able to use 2 forms of contraception from screening until 4 months after the final dose of RV1162. Must not be a woman of child bearing potential for subjects in Part C, OR
•If a woman of non-childbearing potential must be amenorrhoeic for at least 1 year with an appropriate clinical profile, 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 the first dose until 4 months after the final dose of RV1162.
•Have a 12-lead ECG consistent with normal cardiac function
•Capable of complying with all study restrictions and procedures including ability to use the study inhaler correctly.
•Parts A \& B (healthy volunteers only)
•Aged between 18 and 50 years of age inclusive, at the time of signing the informed consent
•Healthy as determined by a physician, based on a full medical evaluation including medical history, physical examination and laboratory tests.
•Vital sign assessments within normal ranges
+11 more criteria

Exclusion Criteria

•Upper or lower respiratory tract infection within 4 weeks of screening
•Clinically significant abnormal values for haematology, clinical chemistry or urinalysis at screening
•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 at screening or prior to dosing
•History of clinically significant allergies that would contraindicate participation
•Known allergy to the study drug or any of the excipients of the formulation
•Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months study drug 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 5 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 pregnancy test at screening or admission, is pregnant, breast-feeding or planning to become pregnant during the study, or is a woman of child bearing potential (subjects in Part C).
•Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B virus (HBV) infection, or hepatitis C antibodies.
+27 more criteria

Locations (1)

Manchester, United Kingdom

Key Dates

Start Date

October 1, 2013

Primary Completion Date

November 1, 2014

Completion Date

November 1, 2014

Last Updated

November 20, 2014

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)Healthy Volunteers

Interventions

RV1162 single dose

DRUG

RV1162 matching placebo single dose

DRUG

RV1162: 7 day repeat dose

DRUG

RV1162 matching placebo: 7 day repeat dose

DRUG

RV1162: 14 day repeat dose

DRUG

RV1162 matching placebo: 14 day repeat dose

DRUG

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

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RECRUITINGPHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

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Healthy ParticipantsHealthy Subjects+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety, Tolerability and Pharmacokinetics (PK) of RV1162 in Healthy Subjects and COPD Patients

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

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