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

NCT00823940 | Completed Phase 1

• 1 other identifier: 111497
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diabetes Mellitus, Type 2

Keywords

FTIH; Glucagon; Safety; GSK1362885; Pharmacokinetics; Tolerability; Pharmacodynamics

Outcome Measures

Primary Outcomes (2)

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

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

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

  24 - 48 hours following each dose

Secondary Outcomes (2)

• Pharmacokinetic parameters to assess dose proportionality and food effect

  24 - 48 hours following each dose

• 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

  24 - 48 hours following each dose

Study Arms (4)

Cohort A1

PLACEBO COMPARATOR

Dose escalation: 5 - 100mg and placebo in 4 planned doses

Drug: GSK1362885

Cohort A2

PLACEBO COMPARATOR

Dose escalation: 100-600mg and placebo in 4 planned doses

Drug: GSK1362885

Cohort B1

OTHER

Glucagon challenge test

Drug: Glucagon

Cohort B3

ACTIVE COMPARATOR

Glucagon challenge test + selected dose of GSK1362885

Drug: Glucagon + GSK1362885

Interventions

GSK1362885 DRUG

5 - 100mg of GSK1362885 or placebo

Cohort A1

Glucagon DRUG

0.5mg IV bolus

Cohort B1

Glucagon + GSK1362885 DRUG

0.5mg Glucagon IV bolus + selected dose of GSK1362885

Cohort B3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Minneapolis, Minnesota, 55404, United States

Location

Related Links

• Results for study 111497 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glucagon

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 16, 2009
• Study Start: January 13, 2009
• Primary Completion: April 27, 2009
• Study Completion: April 27, 2009
• Last Updated: July 7, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)