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Diabetes Mellitus, Type 2Phase 1NCT00823940

A Phase 1 Study to Evaluate the Safety and Tolerability of GSK1362885 in Healthy Normal Subjects

A Phase 1 study testing GSK1362885, Glucagon and Glucagon + GSK1362885 in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in United States.

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

The study will investigate whether GSK1362885 is safe and well-tolerated when administered to normal healthy subjects. The study will also measure blood levels of the study drug to determine how the body processes the drug (pharmacokinetics) and what effects the drug has on the body (pharmacodynamics). Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
GSK1362885, Glucagon and Glucagon + GSK1362885
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
1 siteUnited States
Study dates
13 Jan 2009to 27 Apr 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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • A subject will be eligible for inclusion in this study only if all of the following criteria apply:
  • 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 55 years of age, inclusive, at the time of signing the informed consent.
  • A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
  • BMI within the range 20.0 to 31.9 kg/m2 (inclusive).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Normal cardiac function and ECG parameters, as per protocol.
  • No significant rhythm abnormalities in the Screening Holter ECG recording.

Who cannot join

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • The subject has a positive pre-study drug/alcohol screen. A minimum list of tobacco/drugs that will be screened include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
  • Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
  • History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 drinks/week for men or >7 drinks/week for women.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • History of glycogen storage disease
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  • Unable or unwilling to abstain from:
  • Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices for 7 days prior to the first dose of study medication until the final post-dose assessment at each treatment level.
  • Caffeine-or xanthine-containing products for 24 hours prior to dosing until the final post-dose assessment at each treatment level.
  • Use of illicit drugs
  • Alcohol for 24 hours prior to dosing until final post-dose assessment at each treatment level.
  • Strenuous exercise for 48 hours prior to each blood collection for clinical laboratory tests. Subjects may participate in light recreational activities during studies (e.g., watch television, read).
  • History of uncorrected thyroid dysfunction or an abnormal thyroid function test assessed by TSH and free T4 at screening
  • Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
  • Lactating females.
  • History of any gastrointestinal or hepatic conditions that could impact absorption of the investigational compound.
  • Significant ECG abnormalities as defined per protocol
  • Resting systolic blood pressure < 80 mmHg or > 150 or diastolic blood pressure < 60 mmHg or > 90 mmHg at screening. Resting heart rate is outside the range of 45 to 100 bpm.
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody.
  • A positive test for HIV antibody.
  • A fasting triglyceride level >400mg/dL (4.45mmol/L).
  • Anemia defined by hemoglobin concentration <11.0g/dL for males or <10.0g/lL for females.
  • Significant renal disease as manifested by one or more of the following:
  • Creatinine clearance <80 mL/min. (estimated from serum creatinine (SCr) and demographic data using the MDRD calculation):
  • Urine protein/creatinine (mg/mg) ratio >2.5; or urine albumin concentration >300 g/mg of creatinine.
  • Known loss of a kidney either by surgical ablation, injury, or disease
  • Subjects with values outside the specified ranges for the following key clinical laboratory tests at Screening and at readmission for each treatment period. Laboratory tests may be repeated once to confirm eligibility prior to dosing:
  • Liver function tests: ALT, Direct Bilirubin, or Albumin more than 10% outside the normal reference range (<0.9 x LLN or >1.1 x ULN)
  • Electrolytes: Sodium more than +/- 5mEq/L outside the normal reference range, potassium or Calcium more than 10% outside the normal reference range (<0.9 x LLN or >1.1.x ULN).
  • Metabolic: Glucose more than 10% outside the normal reference range (<0.9 x LLN or >1.1 x ULN), Total Cholesterol >240mg/dl.
  • Muscle: CPK >2 x ULN.
  • Hematology: Hemoglobin, WBC Neutrophils, or Platelets more than 10% outside the normal reference range (<0.9 x LLN or >1.1. x ULN).
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) is prohibited from 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication until the final post-dose assessment, 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 sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
  • Unable or unwilling to discontinue aspirin use during the study. Subjects who are taking low-dose aspirin for cardiovascular prophylaxis (81 mg or less) are eligible to participate in the study, but the aspirin must be discontinued from Screening through the Follow-up visit.
  • Other
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • As a result of the medical interview, physical examination, or screening investigations, the investigator considers the subject unfit for the study.
  • Subject is either an immediate family member of a participating investigator, study coordinator, employee of an investigator; or is a member of the staff conducting the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Minneapolis, Minnesota, 55404

Other trials in United States

About this study

Official title: A Single-blind, Randomized, Placebo Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK1362885 in Healthy Normal Subjects.

The study will investigate whether GSK1362885 is safe and well-tolerated when administered to normal healthy subjects. The study will also measure blood levels of the study drug to determine how the body processes the drug (pharmacokinetics) and what effects the drug has on the body (pharmacodynamics).

Read the detailed description

GSK1362885 is a glycogen phosphorylase inhibitor that is targeted as a treatment for Type 2 Diabetes Mellitus by reducing hepatic glucose output. This study will investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics when single doses of GSK1362885 are administered to healthy volunteers. A glucagon challenge test will be used to stimulate hepatic glucose output in order to evaluate liver glycogen phosphorylase inhibition by GSK1362885.

Being tested
GSK1362885, Glucagon, Glucagon + GSK1362885
Keywords
FTIH, Glucagon, Safety, GSK1362885, Pharmacokinetics, Tolerability, Pharmacodynamics
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK1362885Drug

    5 - 100mg of GSK1362885 or placebo

  • GSK1362885Drug

    100 - 600mg or placebo

  • GlucagonDrug

    0.5mg IV bolus

  • Glucagon + GSK1362885Drug

    0.5mg Glucagon IV bolus + selected dose of GSK1362885

Study groups in NCT00823940
Study groupRoleWhat they receive
Cohort A1Placebo comparatorDose escalation: 5 - 100mg and placebo in 4 planned doses
Receives: Drug: GSK1362885
Cohort A2Placebo comparatorDose escalation: 100-600mg and placebo in 4 planned doses
Receives: Drug: GSK1362885
Cohort B1OtherGlucagon challenge test
Receives: Drug: Glucagon
Cohort B3Active comparatorGlucagon challenge test + selected dose of GSK1362885
Receives: Drug: Glucagon + GSK1362885

What is being measured

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

  1. Safety and tolerability assessments including adverse events, clinical laboratory tests, electrocardiogram (ECG) and vital signs

    Measured: During the duration of study participation (from 2 days up to 5 weeks)

  2. Pharmacokinetic parameters: AUC, Cmax, Tmax, t1/2, tlag, Cl/F, and V/F

    Measured: 24 - 48 hours following each dose

Secondary outcomes (2)

  1. Pharmacokinetic parameters to assess dose proportionality and food effect

    Measured: 24 - 48 hours following each dose

  2. Pharmacodynamic parameters may include change from baseline in glucose, insulin, C-peptide and AUC following administration of IV glucagon in a standardized GC test with and without prior administration of GSK1362885

    Measured: 24 - 48 hours following each dose

Timeline

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

  1. First posted16 Jan 2009 (estimated)
  2. Study start13 Jan 2009
  3. Primary completion27 Apr 2009
  4. Study completion27 Apr 2009

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00823940
Sponsor's protocol ID
111497
Status last verified
Jul 2017
First submitted
15 Jan 2009
Last updated
7 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK1362885, Glucagon and Glucagon + GSK1362885 in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in United States.

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 42 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 7 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 States. 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 assessments including adverse events, clinical laboratory tests, electrocardiogram (ECG) and vital signs (time frame: During the duration of study participation (from 2 days up to 5 weeks)). 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 NCT00823940.

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 7 Jul 2017.

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