Single and Repeat Dose First Time in Human Study for an Intranasal H1/H3 Dual Antagonist in Healthy Male Subjects

NCT ID: NCT00694993

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-17
• Study Completion Date: 2008-05-26

Brief Summary

This is a double-blind, placebo-controlled, randomized single dose escalation study and a double-blind, placebo-controlled, randomised parallel group 14-days once daily repeat dose study to investigate safety, tolerability and pharmacokinetics of an intranasal H1/H3 dual antagonist compound in healthy male subjects.

Detailed Description

A double-blind, placebo-controlled, randomized single dose escalation study and a double-blind, placebo-controlled, randomised parallel group 14-days once daily repeat dose study to investigate safety, tolerability and pharmacokinetics of an intranasal H1/H3 dual antagonist compound in healthy male subjects.

Conditions

Rhinitis, Allergic, Seasonal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT

Study Groups

Subjects receiving GSK1004723 + placebo in cohort I and II

Eligible subjects will receive GSK1004723 nasal spray with single doses of 50 micrograms, 100 micrograms, 200 micrograms, 500 micrograms and 1000 micrograms. Subjects will also receive placebo nasal spray.

Group Type: EXPERIMENTAL

GSK1004723

Intervention Type: DRUG

GSK1004723 will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.

Placebo

Intervention Type: DRUG

Placebo will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.

Subjects receiving GSK1004723 200 micrograms in cohort III

Eligible subjects will receive nasal spray of GSK1004723 with escalated repeat doses of 200 micrograms given once daily for 14 days.

Group Type: EXPERIMENTAL

GSK1004723

Intervention Type: DRUG

GSK1004723 will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.

Subjects receiving placebo in cohort III

Eligible subjects will receive nasal spray of placebo given once daily for 14 days.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.

Subjects receiving GSK1004723 1000 micrograms in cohort IV

Eligible subjects will receive nasal spray of GSK1004723 with escalated repeat doses of 1000 micrograms given once daily for 14 days.

Group Type: EXPERIMENTAL

GSK1004723

Intervention Type: DRUG

GSK1004723 will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.

Subjects receiving placebo in cohort IV

Eligible subjects will receive nasal spray of placebo given once daily for 14 days.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.

Interventions

GSK1004723

GSK1004723 will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.

Intervention Type: DRUG

Placebo

Placebo will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male subjects aged between 18 and 50 years inclusive.
• Body mass index within the range 19-29.9kg/m2 (inclusive), with weight range of 50 kg-100 kg (inclusive).
• Healthy (defined as individuals who are free from significant nasal, cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, malignancy, endocrine, neurological and psychiatric disease as determined by history, physical examination and screening investigations).
• Non-smoking status as verified by urinary cotinine levels below 500 ng/mL cotinine at the screening visit. This can include ex-smokers who have given up smoking for >1 year.
• Normal nasal examination as per Ear, Nose and Throat (ENT) assessment
• No significant ECG abnormalities and QTc (B) <450 msec.
• The subject is able and willing to give written informed consent to take part in the study and is available to complete all study measurements.
• Male subjects must agree to abstain from or use a condom during sexual intercourse with female partners of childbearing potential, to prevent either pregnancy in the female partner or the possible exposure of a pregnant or lactating female to the investigational product from the male subject's semen. In addition, female partners of male subjects must use a reliable contraceptive method listed in the protocol, or they must refrain from sexual intercourse from the first dose of study medication until 84 days after the last dose.

Exclusion Criteria

• As a result of the medical interview, physical examination or screening investigations, the Investigator or appropriately qualified designee considers the subject unfit for the study.
• The subject has a history of drug or any other allergy, which, in the opinion of the Investigator or appropriately qualified designee, contraindicates their participation, including known or suspected personal history or family history of adverse reactions or hypersensitivity to anti histamines
• The subject has participated in a study with a new molecular entity during the previous 3 months or any other study during the previous 2 months.
• The subject regularly, or on average, drinks more than 21 units of alcohol a week or more than an average intake of 3 units per day.
• The subject is currently taking regular (or a course of) medication, prescribed (including all beta-agonists) or not (including over the counter medication or herbal remedies such as St Johns Wort). Paracetamol is an exception and will be permitted at daily doses of up to 4g following the first dose of investigational product.
• The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen.
• The subject has tested positive for HIV.
• The subject has a positive drugs of abuse and alcohol test.
• Donation during the study would result in >500mL of blood being donated over a 56 day period
• Subjects with structural nasal abnormalities frequent nose bleeds, Perennial Allergic Rhinitis (PAR) and Seasonal Allergic Rhinitis (SAR) unless subjects with SAR are asymptomatic and it is outside of the pollen season
• Subjects who are unable to comply with study procedures
• Subject is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study
• Vulnerable subjects (eg. persons kept in detention)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Berlin, , Germany

Countries

Germany

References

Daley-Yates P, Ambery C, Sweeney L, Watson J, Oliver A, McQuade B. The efficacy and tolerability of two novel H(1)/H(3) receptor antagonists in seasonal allergic rhinitis. Int Arch Allergy Immunol. 2012;158(1):84-98. doi: 10.1159/000329738. Epub 2011 Dec 29.

Reference Type: BACKGROUND

PMID: 22212854 (View on PubMed)

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

HHI110157

Identifier Type: -

Identifier Source: org_study_id