Influenza, HumanPhase 1NCT01428479
Phase1 Study of GR121167, Single and Multiple Dose Study in Healthy Japanese Males
A Phase 1 study testing GR121167 Solution in people with Influenza, Human, run by GlaxoSmithKline at 1 site in Japan.
Trial summary
This study is a randomized, double-blind, ascending dose, placebo-controlled, incomplete crossover, single and multiple dose study in healthy Japanese male subjects to assess the pharmacokinetics and safety/tolerability of single and multiple intravenous administration of GR121167. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- GR121167 Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteJapan
- Study dates
- 7 Jan 2011to 4 Apr 2011
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as defined as being free from clinically significant illness or disease as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital sign, laboratory tests and ECG.
- Japanese healthy male between 20 and 55 years of age inclusive, at the time of signing the informed consent.
- Body weight >= 50.0 kg and BMI within the range 18.5<= - <25.0 kg/m2 (inclusive).
- A creatinine clearance >= 80ml/min as determined by Cockcroft-Gault equation:CLcr (mL/min) = (140 - age) * Wt / (72 * Scr). Where age is in years, weight (wt) is in kg, and serum creatinine (Scr) is in units of mg/dl. [Cockcroft, 1976]
- Non-smoker or ex-smoker having ceased smoking for at least 6 months.
- AST, ALT, alkaline phosphatase and total bilirubin =< ULN at screening.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- A positive test for syphilis, Hepatitis B surface antigen or positive Hepatitis C antibody, HIV antigen /antibody, HTLV-1 at screening
- A positive pre-study drug screen at screening.
- History of regular alcohol consumption exceeding, on average, 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 350 mL of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening.
- The subject had participated in a clinical study or post-marketing study with an investigational or a non-investigational product during the previous 4 months preceding the first dose of study medication of this study
- The subject planned to concurrently participate in another clinical study or post-marketing study.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
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- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy excluding pollen allergy without current symptoms.
- Where participation in the study would result in donation of blood or blood products in excess of 400 mL within 4 month or 200 mL within 2 months.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Consumption of red wine, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
- Single QTcB >= 450 msec; at screening
- Subjects with ECG results considered clinically significant by the investigator.
- Subjects with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes or additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia).
- Subjects with a family history of sudden cardiac death.
- Subjects with a supine systolic blood pressure <90mmHg or >140mmHg and/or a supine diastolic blood pressure <55mmHg or >90mmHg and/or systolic blood pressure drop from supine to standing of >30mmHg.
- History of renal failure or renal dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase1 Study of GR121167- A Double Blind, Placebo Controlled, Randomized, Dose Ascending, Single and Multiple Dose Study to Investigate the Safety and Pharmacokinetics Following Intravenous Administration of GR121167 in Healthy Japanese Males-
This study is a randomized, double-blind, ascending dose, placebo-controlled, incomplete crossover, single and multiple dose study in healthy Japanese male subjects to assess the pharmacokinetics and safety/tolerability of single and multiple intravenous administration of GR121167. Serial blood samples and pooled urine samples for the determination of GR121167 concentration will be collected and safety assessments will be performed for each treatment period.
The pharmacokinetics and dose proportionality of GR121167 after single intravenous administration of GR121167 at the dose levels of 100 mg, 300 mg and 600 mg will be assessed. In addition, in the final treatment period (600 mg), twice daily intravenous administrations for 5 days will be also conducted and the pharmacokinetics and accumulation will be assessed.
- Conditions
- Influenza, Human
- Being tested
- GR121167 Solution, Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GR121167 SolutionDrug
GR121167 solution will be administered intravenously. For 100 mg subject will receive 10 milliliter (mL) of solution, 30 mL for 300 mg and 60 mL for 600 mg
PlaceboDrug
Placebo solution will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A | Experimental | In Arm A subjects will receive 100 mg of GR121167 in Period 1 and 300 mg of GR121167 in Period 2. In Period 3 subject will receive single doses of placebo on Day 1 and multiple doses of placebo from Day 3 to Day 8 Receives: Drug: GR121167 Solution; Drug: Placebo |
| Treatment Arm B | Experimental | In Arm B subjects will receive 100 mg of GR121167 in Period 1 and placebo in Period 2. In Period 3 subject will receive 600 mg of GR121167 as single dose on Day 1 and multiple doses of GR121167 from Day 3 to Day8 Receives: Drug: GR121167 Solution; Drug: Placebo |
| Treatment Arm C | Experimental | In Arm C subjects will receive placebo in Period 1, 300 mg of GR121167 in Period 2. In period 3 subject will receive 600 mg of GR121167 single dose on Day 1 and multiple doses from Day 3 to Day 8 Receives: Drug: GR121167 Solution; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of pharmacokinetics
Cmax, AUC0-inf, AUC0-last, AUC0-12, C12 (Cτ), accumulation ratios (Ro, Rs)
Measured: Pre, 0.5, 0.75, 1, 1.5, 2, 4, 6 ,8 ,10 ,12 ,24 hrs after single dose and 5 days multiple dose, and at the trough during multiple doses
Safety parameters
vital signs, ECGs, clinical laboratory tests, and adverse events
Measured: upto 24 hrs after dose and 7 days after final dose
Secondary outcomes (2)
Profile of urinary pharmacokinetics
Ae, fe, CLr
Measured: 0-4, 4-8, 8-12, 12-24hrs after single dose
Profile of serum pharmacokinetics
AUC0-24, %AUCex, λz, tmax, t1/2, CL, Vz, Vss
Measured: Pre, 0.5, 0.75, 1, 1.5, 2, 4, 6 ,8 ,10 ,12 ,24 hrs after single dose and 5 days multiple dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study start7 Jan 2011
- Primary completion4 Apr 2011
- Study completion4 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 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
- NCT01428479
- Sponsor's protocol ID
- 115070
- Status last verified
- Jul 2017
- First submitted
- 23 Jun 2011
- Last updated
- 21 Jul 2017
- Results posted
- 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 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase1 Study of GR121167- A Double Blind, Placebo Controlled, Randomized, Dose Ascending, Single and Multiple Dose Study to Investigate the Safety and Pharmacokinetics Following Intravenous Administration of GR121167 in Healthy Japanese Males-
- ClinicalTrials.gov ID
- NCT01428479
- Acronym / sponsor ID
- 115070
- Conditions
- Influenza, Human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2011 (actual)
- Primary completion
- 4 Apr 2011 (actual)
- Study completion
- 4 Apr 2011 (actual)
- First posted
- 5 Sep 2011 (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 study is a randomized, double-blind, ascending dose, placebo-controlled, incomplete crossover, single and multiple dose study in healthy Japanese male subjects to assess the pharmacokinetics and safety/tolerability of single and multiple intravenous administration of GR121167. Serial blood samples and pooled urine samples for the determination of GR121167 concentration will be collected and safety assessments will be performed for each treatment period.
The pharmacokinetics and dose proportionality of GR121167 after single intravenous administration of GR121167 at the dose levels of 100 mg, 300 mg and 600 mg will be assessed. In addition, in the final treatment period (600 mg), twice daily intravenous administrations for 5 days will be also conducted and the pharmacokinetics and accumulation will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A | Experimental | Drug: GR121167 Solution, Drug: PlaceboIn Arm A subjects will receive 100 mg of GR121167 in Period 1 and 300 mg of GR121167 in Period 2. In Period 3 subject will receive single doses of placebo on Day 1 and multiple doses of placebo from Day 3 to Day 8 |
| Treatment Arm B | Experimental | Drug: GR121167 Solution, Drug: PlaceboIn Arm B subjects will receive 100 mg of GR121167 in Period 1 and placebo in Period 2. In Period 3 subject will receive 600 mg of GR121167 as single dose on Day 1 and multiple doses of GR121167 from Day 3 to Day8 |
| Treatment Arm C | Experimental | Drug: GR121167 Solution, Drug: PlaceboIn Arm C subjects will receive placebo in Period 1, 300 mg of GR121167 in Period 2. In period 3 subject will receive 600 mg of GR121167 single dose on Day 1 and multiple doses from Day 3 to Day 8 |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy as defined as being free from clinically significant illness or disease as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital sign, laboratory tests and ECG.
- Japanese healthy male between 20 and 55 years of age inclusive, at the time of signing the informed consent.
- Body weight >= 50.0 kg and BMI within the range 18.5<= - <25.0 kg/m2 (inclusive).
- A creatinine clearance >= 80ml/min as determined by Cockcroft-Gault equation:CLcr (mL/min) = (140 - age) * Wt / (72 * Scr). Where age is in years, weight (wt) is in kg, and serum creatinine (Scr) is in units of mg/dl. [Cockcroft, 1976]
- Non-smoker or ex-smoker having ceased smoking for at least 6 months.
Key exclusion criteria (16 listed)
- A positive test for syphilis, Hepatitis B surface antigen or positive Hepatitis C antibody, HIV antigen /antibody, HTLV-1 at screening
- A positive pre-study drug screen at screening.
- History of regular alcohol consumption exceeding, on average, 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 350 mL of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening.
- The subject had participated in a clinical study or post-marketing study with an investigational or a non-investigational product during the previous 4 months preceding the first dose of study medication of this study
- The subject planned to concurrently participate in another clinical study or post-marketing study.
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 |
|---|---|---|
| GR121167 SolutionGR121167 solution will be administered intravenously. For 100 mg subject will receive 10 milliliter (mL) of solution, 30 mL for 300 mg and 60 mL for 600 mg | Drug | Treatment Arm A, Treatment Arm B, Treatment Arm C |
| PlaceboPlacebo solution will be administered intravenously. | Drug | Treatment Arm A, Treatment Arm B, Treatment Arm C |
Primary outcome
Profile of pharmacokinetics
Time frame: Pre, 0.5, 0.75, 1, 1.5, 2, 4, 6 ,8 ,10 ,12 ,24 hrs after single dose and 5 days multiple dose, and at the trough during multiple doses
Cmax, AUC0-inf, AUC0-last, AUC0-12, C12 (Cτ), accumulation ratios (Ro, Rs)
Safety parameters
Time frame: upto 24 hrs after dose and 7 days after final dose
vital signs, ECGs, clinical laboratory tests, and adverse events
2 secondary outcomes
Profile of urinary pharmacokinetics
Time frame: 0-4, 4-8, 8-12, 12-24hrs after single dose
Profile of serum pharmacokinetics
Time frame: Pre, 0.5, 0.75, 1, 1.5, 2, 4, 6 ,8 ,10 ,12 ,24 hrs after single dose and 5 days multiple dose
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 21 Jul 2017.
- Results for study 115070 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- 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.
- 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 GR121167 Solution in people with Influenza, Human, run by GlaxoSmithKline at 1 site in Japan.
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 7 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 21 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 Japan. 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?
Profile of pharmacokinetics (time frame: Pre, 0.5, 0.75, 1, 1.5, 2, 4, 6 ,8 ,10 ,12 ,24 hrs after single dose and 5 days multiple dose, and at the trough during multiple doses). 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?
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 Jul 2017.