Rhinitis, Allergic, SeasonalPhase 1NCT00694993
Single and Repeat Dose First Time in Human Study for an Intranasal H1/H3 Dual Antagonist in Healthy Male Subjects
A Phase 1 study testing GSK1004723 in people with Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- GSK1004723
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteGermany
- Study dates
- 17 Dec 2007to 26 May 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- GSK1004723, Placebo
- Keywords
- first time in human, Allergic rhinitis,
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1004723Drug
GSK1004723 will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.
PlaceboDrug
Placebo will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving GSK1004723 + placebo in cohort I and II | Experimental | 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. Receives: Drug: GSK1004723; Drug: Placebo |
| Subjects receiving GSK1004723 200 micrograms in cohort III | Experimental | Eligible subjects will receive nasal spray of GSK1004723 with escalated repeat doses of 200 micrograms given once daily for 14 days. Receives: Drug: GSK1004723 |
| Subjects receiving placebo in cohort III | Experimental | Eligible subjects will receive nasal spray of placebo given once daily for 14 days. Receives: Drug: Placebo |
| Subjects receiving GSK1004723 1000 micrograms in cohort IV | Experimental | Eligible subjects will receive nasal spray of GSK1004723 with escalated repeat doses of 1000 micrograms given once daily for 14 days. Receives: Drug: GSK1004723 |
| Subjects receiving placebo in cohort IV | Experimental | Eligible subjects will receive nasal spray of placebo given once daily for 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG monitoring during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts.
Measured: 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
Measured: over 24 hours after dosing
Secondary outcomes (1)
Blood drug levels for GSK1004723 following single and repeat intranasal dosing
Measured: Pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study start17 Dec 2007
- Primary completion26 May 2008
- Study completion26 May 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694993
- Sponsor's protocol ID
- HHI110157
- Status last verified
- Aug 2017
- First submitted
- 9 Jun 2008
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
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.
PubMed 22212854
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00694993
- Acronym / sponsor ID
- HHI110157
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- first time in human, Allergic rhinitis,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2007 (actual)
- Primary completion
- 26 May 2008 (actual)
- Study completion
- 26 May 2008 (actual)
- First posted
- 11 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving GSK1004723 + placebo in cohort I and II | Experimental | Drug: GSK1004723, Drug: PlaceboEligible 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. |
| Subjects receiving GSK1004723 200 micrograms in cohort III | Experimental | Drug: GSK1004723Eligible subjects will receive nasal spray of GSK1004723 with escalated repeat doses of 200 micrograms given once daily for 14 days. |
| Subjects receiving placebo in cohort III | Experimental | Drug: PlaceboEligible subjects will receive nasal spray of placebo given once daily for 14 days. |
| Subjects receiving GSK1004723 1000 micrograms in cohort IV | Experimental | Drug: GSK1004723Eligible subjects will receive nasal spray of GSK1004723 with escalated repeat doses of 1000 micrograms given once daily for 14 days. |
| Subjects receiving placebo in cohort IV | Experimental | Drug: PlaceboEligible subjects will receive nasal spray of placebo given once daily for 14 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK1004723GSK1004723 will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration. | Drug | Subjects receiving GSK1004723 + placebo in cohort I and II, Subjects receiving GSK1004723 1000 micrograms in cohort IV, Subjects receiving GSK1004723 200 micrograms in cohort III |
| PlaceboPlacebo will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration. | Drug | Subjects receiving GSK1004723 + placebo in cohort I and II, Subjects receiving placebo in cohort III, Subjects receiving placebo in cohort IV |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Background: PubMed 22212854Daley-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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study HHI110157 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK1004723 in people with Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00694993, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.