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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00694993
First Posted: June 11, 2008
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention Phase
Rhinitis, Allergic, Seasonal Drug: GSK1004723 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • ECG monitoring during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts. [ Time Frame: during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts ]
  • Heart rate and blood pressure changes over 24 hours after dosing in single and repeat dose cohorts [ Time Frame: over 24 hours after dosing ]

Secondary Outcome Measures:
  • Blood drug levels for GSK1004723 following single and repeat intranasal dosing [ Time Frame: Pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours ]

Enrollment: 19
Actual Study Start Date: December 17, 2007
Study Completion Date: May 26, 2008
Primary Completion Date: May 26, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: GSK1004723
GSK1004723 will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.
Drug: Placebo
Placebo will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.
Experimental: 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.
Drug: GSK1004723
GSK1004723 will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.
Experimental: Subjects receiving placebo in cohort III
Eligible subjects will receive nasal spray of placebo given once daily for 14 days.
Drug: Placebo
Placebo will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.
Experimental: 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.
Drug: GSK1004723
GSK1004723 will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.
Experimental: Subjects receiving placebo in cohort IV
Eligible subjects will receive nasal spray of placebo given once daily for 14 days.
Drug: Placebo
Placebo will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694993


Locations
Germany
GSK Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: HHI110157
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: HHI110157
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: HHI110157
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: HHI110157
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: HHI110157
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: HHI110157
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: HHI110157
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00694993     History of Changes
Other Study ID Numbers: HHI110157
First Submitted: June 9, 2008
First Posted: June 11, 2008
Last Update Posted: August 10, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

Keywords provided by GlaxoSmithKline:
first time in human
Allergic rhinitis,

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases