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Rhinitis, Allergic, SeasonalPhase 1NCT00605852

Investigation Of a New Oral Anti-Histamine in Healthy Male Subjects

A Phase 1 study testing GSK835726 in people with Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to assess the safety and tolerability of single, escalating oral doses and repeat oral doses (7 days, once daily) of GSK835726 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?
GSK835726
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
29 participants
Where
1 siteUnited Kingdom
Study dates
29 Oct 2007to 3 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 aged between 18 and 50 years inclusive.
  • Body mass index within the range 19-29kg/m2 (inclusive), with weight range of 55kg-100kg (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 300 ng/mL cotinine at the screening visit. This can include ex-smokers who have given up smoking for >1 year.
  • Subjects to be entered in cohorts I and III only: Skin prick test reactivity to histamine of 3mm wheal > than saline control and some associated surrounding erythema.
  • Subjects to be entered in cohorts I and III only: Negative skin prick test reactivity to saline control.
  • 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.
  • If sexually active, male subjects must agree to use a condom with spermicide during sexual intercourse, from the first dose of the study drug until 84 days after the last dose. In addition, female partners of male subjects, who are of childbearing potential, must use a reliable contraceptive method or they must refrain from sexual intercourse from the first dose of study medication until 84 days after the last dose. Reliable forms of contraception include an IUD, condom or diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants, contraceptive patches or a tubal ligation."

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 (One unit = 125ml wine or 25ml spirits or 250ml normal strength lager).
  • The subject is currently taking regular (or a course of) medication, prescribed (including all anti-allergy medication) 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 all doses of investigational product.
  • The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen.
Show all 21Show fewer
  • The subject has tested positive for HIV.
  • The subject has a positive drugs of abuse and alcohol test.
  • Donation of blood (450 mL or more) within 2 months of screening.
  • Donation during the study would result in >500mL of blood being donated over a 56 day period
  • Significant cardiac conduction abnormalities on two or more ECG tracings separated by at least 5 minutes at screening, including:
  • QTc interval > 450 msec
  • PR interval > 240 msec
  • Evidence of second- or third- degree atrioventricular (AV) block
  • Ventricular rate < 45 beats per minute (bpm) or > 100 bpm
  • Pathological Q-waves (defined as Q-wave > 40 msec or depth greater than 0.4-0.5 mV)
  • Evidence of ventricular pre-excitation
  • Evidence of left axis deviation, non-specific intraventricular conduction delay (QRS duration > 120 msec), or complete left bundle branch block
  • Subjects with Perennial Allergic Rhinitis (PAR) and Seasonal Allergic Rhinitis (SAR), unless subjects with SAR are asymptomatic and it is outside of the pollen season
  • Subjects with dermatographism and other skin conditions that might interfere with the wheal and flare test.
  • Subjects who are unable to comply with study procedures.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • GSK Investigational Site

    London, NW10 7EW

Other trials in United Kingdom

About this study

Official title: A Double-blind, Placebo-controlled, Randomized Cross-over Single Dose Escalation Study and a Double-blind, Placebo-controlled, Randomised Parallel Group 7-days Once Daily Repeat Dose Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral H1/H3 Dual Antagonist Compound in Healthy Male Subjects

This study is designed to assess the safety and tolerability of single, escalating oral doses and repeat oral doses (7 days, once daily) of GSK835726 in healthy male subjects

Read the detailed description

A double-blind, placebo controlled, randomized cross-over single dose escalation study and a double-blind, placebo controlled, randomised parallel group 7-days once daily repeat dose study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of oral H1/H3 dual antagonist compound in healthy male subjects

Being tested
GSK835726, Placebo
Keywords
Allergic rhinitis, first time in human
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.

  • GSK835726Drug

    GSK835726 will be available in single dose and repeat dose formulations.

  • PlaceboDrug

    Placebo will be given to subjects.

Study groups in NCT00605852
Study groupRoleWhat they receive
Subjects receiving treatment in cohort IExperimentalEligible subjects will receive three single doses of GSK835726 and one single dose of placebo in cohort I.
Receives: Drug: GSK835726; Drug: Placebo
Subjects receiving GSK835726 in cohort IIExperimentalEligible subjects will receive repeat doses of GSK835726 once daily for 7 days.
Receives: Drug: GSK835726
Subjects receiving placebo in cohort IIPlacebo comparatorEligible subjects will receive repeat doses of placebo once daily for 7 days.
Receives: Drug: Placebo
Subjects receiving treatment in cohort IIIExperimentalEligible subjects will receive two single doses of GSK835726 and one single dose of placebo in cohort III.
Receives: Drug: GSK835726; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  2. Heart rate and blood pressure changes over 24 hours after dosing in single and repeat dose cohorts

    Measured: over 24 hours after dosing in single and repeat dose cohorts

Secondary outcomes (4)

  1. Change in plasma drug concentration (AUC, Cmax, t1/2, tmax)

    Measured: over 24 hours after dosing

  2. Changes in histamine-induced wheal and flare measurements

    Measured: over 24 hours after dosing

  3. Derived pharmacokinetic parameters for GSK835726 including area under the plasma drug concentration versus time curve (AUC(0-t), AUC(0-¥)), maximum observed plasma drug concentration (Cmax),

    Measured: over 24 hours after dosing

  4. time to maximum observed plasma drug concentration (tmax), apparent clearance (CL/F) and terminal half life (t1/2) following single and repeat oral dosing.

    Measured: over 24 hours after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2008 (estimated)
  2. Study start29 Oct 2007
  3. Primary completion3 May 2008
  4. Study completion3 May 2008

Resources

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
Crossover
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00605852
Sponsor's protocol ID
HH3110161
Status last verified
Aug 2017
First submitted
18 Jan 2008
Last updated
21 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK835726 in people with Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 1 site in United Kingdom.

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 21 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 21 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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 NCT00605852, 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 21 Aug 2017.

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