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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00680485




Registration number
NCT00680485
Ethics application status
Date submitted
14/04/2008
Date registered
20/05/2008
Date last updated
20/01/2017

Titles & IDs
Public title
Evaluation of the Safety, Tolerability and Pharmacokinetics of Repeat Oral Doses of GSK580416
Scientific title
A Three Part Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of Repeat Escalating Oral Doses of GSK580416; the Safety, Tolerability, and Pharmacokinetics of GSK580416 Following a Loading Dose Regimen; and the Effect of Ketoconazole on the Pharmacokinetics of GSK580416
Secondary ID [1] 0 0
OPS108221
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial Infection 0 0
Infections, Bacterial 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK580416 oral tablets (250 mg) Ketoconazole oral tablets (200 mg)

Treatment: Drugs: GSK580416 oral tablets (250 mg) Ketoconazole oral tablets (200 mg)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of GSK580416 doses determined from clinical safety and tolerability data from all adverse event reporting, 12-lead ECGs, vital signs, nursing/physician observation, and safety laboratory tests
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Pharmacokinetics of GSK580416 as determined by AUC, Cmax, tmax, half-life, and Ct.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Healthy adults (as determined by medical evaluation including history, physical exam,
vital signs, laboratory tests, and cardiac monitoring)

- Aged 18-60yrs, with BMI of 19-31kg/m2.

- Females must be of non-childbearing potential.

- QTc < 450 msec at screening.

- Subjects must be able to give consent and comply with restrictions of study.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Clinically significant CNS, cardiac, pulmonary, metabolic, renal, hepatic or GI
condition or history that may place the subject at an unacceptable risk or may
interfere with absorption, distribution, metabolism, or excretion of drug.

- Positive urine drug screen.

- Positive urine test for alcohol.

- Positive HIV or Hep B and/or C assay.

- History of regular tobacco use within 3 monts prior to screening or cotinine levels
indicative of smoking at screening.

- History of regular alcohol consumption (14 units/week for women and 21 units/week for
men).

- History of drug abuse or dependence within 12 months of study.

- Participation in another drug trial within 30 days of first dose.

- Exposure to more than 4 new chemical entities within 12 months of first dose.

- Use of prescription and non-prescription drugs including vitamins, dietary
supplements, herbals within 7 days of first dose or St. John's Wort within 28 days of
the first dose.

- Consumption of red wine, Seville oranges, grapefruit, or grapefruit juices within 14
days of first dose.

- Donation of blood in excess of 500 mL within 56 days of dosing. No blood donation is
allowed 30 days prior to study participation.

- A positive immunochemical fecal occult blood test at screening.

- History of sensitivity to any of the study medications.

- History of sensitivity to heparin or heparin-induced thrombocytopenia.

- History of orthostatic hypotension or orthostatic hypotension at screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
GSK Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety, tolerability and exposure of repeat escalating oral
doses, a loading dose/maintenance dose regimen of GSK580416 and when co administered with
ketoconazole, a PGP/CYP3A4 inhibitor.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00680485
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00680485