RhinitisPhase 1NCT00907933
Intranasal SB-705498 in Healthy Volunteers
A Phase 1 study testing SB-705498 in people with Rhinitis, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This is a First Time in Human (FTIH) study to investigate the safety, tolerability and pharmacokinetics (PK) of a) single, escalating and b) twice-daily 14 days repeat doses of intranasal SB-705498 in healthy volunteers (HVT). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinitis
- What is being tested?
- SB-705498
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Nov 2008to 11 Feb 2009
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 60 years of age inclusive.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as females with documented tubal occlusion, bilateral salpingectomy, bilateral oophorectomy or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous FSH > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2-4 weeks should elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
- Child-bearing potential and agrees to use one of the contraception methods listed in the protocol. Female subjects willing to participate in the study must agree to use contraception from the screening visit until 15 days post-last treatment administration.
- Male subjects must agree to use one of the contraception methods listed in the protocol. For male subjects willing to participate in the study this criterion must be followed from the time of the screening visit until 15 days post-last treatment administration.
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- Non-smoker for at least 6 months with a pack history less than or equal to 5 pack years (Pack years = (No. of cigarettes smoked/day/20) x No. of years smoked).
- Body weight greater than or equal to 50 kg and body mass index (BMI) within the range 19 - 29.9 kg/m2 (inclusive).
- Normal assessment of vital signs and 12-lead ECG at screening. A subject may be included in the study if any abnormality is deemed not clinically significant by the Investigator.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Available to complete all the required study measurements.
Who cannot join
- Past medical history of rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis. Subjects with recent upper respiratory tract infections (URTIs) will be allowed in the study only if their nasal symptoms have been completely resolved for more than 3 weeks prior to screening.
- Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations.
- History of frequent nosebleeds.
- A history of gastro-intestinal, hepatic, renal or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
- Positive pre-study drug/alcohol/smoking screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids, benzodiazepines and methadone.
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- Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for human immunodeficiency virus (HIV) antibody.
- Exposure to more than four new chemical entities within 6 months prior to the start of the study.
- Participation in a clinical trial with a new molecule entity or any other clinical trial within 3 months of the start of the study.
- Use of prescription or non-prescription drugs, as well as of vitamins, herbal and dietary supplements (including St John's Wort) within 7 days prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates participation in this study.
- Donation of blood or blood products in excess of 500mL within a 56 day period prior the start of this study.
- Pregnant females as determined by positive serum or urine beta-human chorionic gonadatrophin (beta-hCG) test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study in Healthy Volunteers to Examine the Safety, Tolerability and Pharmacokinetics of a) Single, Ascending and b) Twice-daily Repeat Doses of Intranasal SB-705498
This is a First Time in Human (FTIH) study to investigate the safety, tolerability and pharmacokinetics (PK) of a) single, escalating and b) twice-daily 14 days repeat doses of intranasal SB-705498 in healthy volunteers (HVT). The safety and tolerability of single intranasal 498 dosing will be assessed and established before initiating the evaluation of repeat intranasal 498 dosing.
- Conditions
- Rhinitis
- Being tested
- SB-705498, Placebo
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-705498Drug
0.5mg intranasal SB-705498
SB-705498Drug
1.5mg intranasal SB-705498
SB-705498Drug
3mg intranasal SB-705498
SB-705498Drug
6mg intranasal SB-705498
SB-705498Drug
12mg intranasal SB-705498
PlaceboDrug
Placebo '498
SB-705498Drug
6mg intranasal SB-705498 for 14 days bid
SB-705498Drug
12mg intranasal SB-705498 14 days bid
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Arm 1 | Experimental | HVTs Receives: Drug: SB-705498 |
| Part 2 - Arm 3 | Placebo comparator | HVTs Receives: Drug: Placebo |
| Part 1 - Arm 2 | Experimental | HVTs Receives: Drug: SB-705498 |
| Part 1 - Arm 3 | Experimental | HVTs Receives: Drug: SB-705498 |
| Part 1 - Arm 4 | Experimental | HVTs Receives: Drug: SB-705498 |
| Part 1 - Arm 5 | Experimental | HVTs Receives: Drug: SB-705498 |
| Part 1 - Arm 6 | Placebo comparator | HVTs Receives: Drug: Placebo |
| Part 2 - Arm 1 | Experimental | HVTs Receives: Drug: SB-705498 |
| Part 2 - Arm 2 | Experimental | HVTs Receives: Drug: SB-705498 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability (Electrocardiogram, vital signs, lab tests, AEs and nasal tolerability
Measured: Various
Secondary outcomes (1)
Part 1: Single dose derived pharmacokinetics (Cmax, tmax, AUC(0-4) and AUC(o-infinity); Part 2: Repeat dose derived pharmacokinetics (Cmax, tmax, AUC(0-4) and AUC(o-infinity)
Measured: Part 1: Various timepoints through the day; Part 2: Various timepoints over 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study start10 Nov 2008
- Primary completion11 Feb 2009
- Study completion11 Feb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinitisStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 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
- NCT00907933
- Sponsor's protocol ID
- 111610
- Status last verified
- Jul 2017
- First submitted
- 30 Apr 2009
- Last updated
- 13 Jul 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study in Healthy Volunteers to Examine the Safety, Tolerability and Pharmacokinetics of a) Single, Ascending and b) Twice-daily Repeat Doses of Intranasal SB-705498
- ClinicalTrials.gov ID
- NCT00907933
- Acronym / sponsor ID
- 111610
- Conditions
- Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2008 (actual)
- Primary completion
- 11 Feb 2009 (actual)
- Study completion
- 11 Feb 2009 (actual)
- First posted
- 25 May 2009 (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 First Time in Human (FTIH) study to investigate the safety, tolerability and pharmacokinetics (PK) of a) single, escalating and b) twice-daily 14 days repeat doses of intranasal SB-705498 in healthy volunteers (HVT). The safety and tolerability of single intranasal 498 dosing will be assessed and established before initiating the evaluation of repeat intranasal 498 dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Arm 1 | Experimental | Drug: SB-705498HVTs |
| Part 2 - Arm 3 | Placebo comparator | Drug: PlaceboHVTs |
| Part 1 - Arm 2 | Experimental | Drug: SB-705498HVTs |
| Part 1 - Arm 3 | Experimental | Drug: SB-705498HVTs |
| Part 1 - Arm 4 | Experimental | Drug: SB-705498HVTs |
| Part 1 - Arm 5 | Experimental | Drug: SB-705498HVTs |
| Part 1 - Arm 6 | Placebo comparator | Drug: PlaceboHVTs |
| Part 2 - Arm 1 | Experimental | Drug: SB-705498HVTs |
| Part 2 - Arm 2 | Experimental | Drug: SB-705498HVTs |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy, as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 60 years of age inclusive.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as females with documented tubal occlusion, bilateral salpingectomy, bilateral oophorectomy or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous FSH > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2-4 weeks should elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
- Child-bearing potential and agrees to use one of the contraception methods listed in the protocol. Female subjects willing to participate in the study must agree to use contraception from the screening visit until 15 days post-last treatment administration.
Key exclusion criteria (16 listed)
- Past medical history of rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis. Subjects with recent upper respiratory tract infections (URTIs) will be allowed in the study only if their nasal symptoms have been completely resolved for more than 3 weeks prior to screening.
- Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations.
- History of frequent nosebleeds.
- A history of gastro-intestinal, hepatic, renal or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
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 |
|---|---|---|
| SB-7054980.5mg intranasal SB-705498 | Drug | Part 1 - Arm 1 |
| SB-7054981.5mg intranasal SB-705498 | Drug | Part 1 - Arm 2 |
| SB-7054983mg intranasal SB-705498 | Drug | Part 1 - Arm 3 |
| SB-7054986mg intranasal SB-705498 | Drug | Part 1 - Arm 4 |
| SB-70549812mg intranasal SB-705498 | Drug | Part 1 - Arm 5 |
| PlaceboPlacebo '498 | Drug | Part 1 - Arm 6 |
| SB-7054986mg intranasal SB-705498 for 14 days bid | Drug | Part 2 - Arm 1 |
| SB-70549812mg intranasal SB-705498 14 days bid | Drug | Part 2 - Arm 2 |
| PlaceboPlacebo | Drug | Part 2 - Arm 3 |
Primary outcome
Safety and tolerability (Electrocardiogram, vital signs, lab tests, AEs and nasal tolerability
Time frame: Various
1 secondary outcome
Part 1: Single dose derived pharmacokinetics (Cmax, tmax, AUC(0-4) and AUC(o-infinity); Part 2: Repeat dose derived pharmacokinetics (Cmax, tmax, AUC(0-4) and AUC(o-infinity)
Time frame: Part 1: Various timepoints through the day; Part 2: Various timepoints over 14 days
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 13 Jul 2017.
- 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 111610 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 SB-705498 in people with Rhinitis, 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 11 inclusion and 16 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 13 Jul 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?
Safety and tolerability (Electrocardiogram, vital signs, lab tests, AEs and nasal tolerability (time frame: Various). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2017.