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Kidney DiseasePhase 1NCT00840320

Repeat Dose Safety Study for Compound to Treat Anemia

A Phase 1 study testing 1278863 in people with Kidney Disease, run by GlaxoSmithKline at 1 site in Australia.

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 purpose of this study is to characterize the safety and tolerability of repeat doses of compound 1278863A in healthy subjects. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Kidney Disease
What is being tested?
1278863
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteAustralia
Study dates
13 Mar 2009to 2 Sep 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

  • 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.
  • A female subject must be of non-childbearing potential.
  • Male subjects must agree to use one of the acceptable contraception methods listed in the protocol
  • Body weight greater than or equal to 50 kg and BMI within the range 19 - 31 kg/m2 (inclusive).
  • Capable of giving written informed consent
  • QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.

Who cannot join

  • The subject has a positive pre-study drug screen.
  • A hemoglobin value at screening is:
  • Male subjects or post-menopausal females: > 15.5 g/dL
  • Female subjects: > 14.5 g/dL
  • The values of hematological parameters at screening are:
  • MCV: outside the reference range and clinically significant deemed by the investigator and GSK Medical Monitor
Show all 32Show fewer
  • The values of the following tests at screening are:
  • TIBC: outside the reference range
  • Serum iron: outside the reference range
  • Serum ferritin: outside the reference range
  • A value at screening is greater than the upper limit of reference range for the following clinical laboratory parameters: AST, ALT, direct bilirubin.
  • Clinically significant abnormal CPK determined by the investigator and GSK Medical Monitor.
  • Calculated creatinine clearance: < 60mL/min
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
  • A positive test for HIV antibody.
  • History of drug abuse or dependence within 6 months of the study.
  • History of regular alcohol consumption within 6 months of the study
  • Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 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 drug
  • History of sensitivity to any of the study drugs, 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.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia. (if the clinical research unit uses heparin to maintain intravenous cannula patency)
  • Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, and/or hepatic function that could interfere with the absorption, metabolism, and/or excretion of the study drugs.
  • History of peptic ulcer disease.
  • History of malignancy tumor. Non-melanoma skin cancer that has been definitely removed is allowed.
  • Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
  • Lactating females.
  • 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, or lifestyle and/or dietary restrictions outlined in the protocol.
  • Consumption of red wine, seville oranges, grapefruit or grapefruit juice, exotic citrus fruits, grapefruit hybrids or fruit juices of the prohibited fruits from 7 days prior to the first dose of study medication
  • 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.
  • Subject is mentally or legally incapacitated.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • GSK Investigational Site

    Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: A Phase I, Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Repeat Oral Doses of 1278863A in Healthy Subjects

The purpose of this study is to characterize the safety and tolerability of repeat doses of compound 1278863A in healthy subjects.

Read the detailed description

Compound 1278863A is a novel small molecule agent, which stimulates erythropoiesis through inhibition of hypoxia-inducible factor (HIF)-prolyl hydroxylases (EGLNs). This compound is being developed for the treatment of anemia. Compound 111427 was the first administration of compound 1278863A to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral doses up to 300 mg in healthy adult subjects. This study, PHI112842, will be the first administration of compound 1278863A to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of repeat oral doses up to 300 mg for 14 days in healthy adult subjects. At least 6 subjects will complete each cohort. Multiple blood samples for pharmacokinetic analyses will be obtained post-dose in each cohort. Safety will be assessed by measurement of vital signs, cardiac monitoring, collection of adverse event assessments and laboratory safety tests. Blood samples will be collected for pharmacodynamic analyses.

Conditions
Kidney Disease
Being tested
1278863, Placebo
Keywords
Safety, tolerability
Medical subject headings
Kidney Diseases

What participants receive

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

  • 1278863Drug

    15mg, 25mg, 50mg, 150mg

  • PlaceboDrug

    matching placebo

Study groups in NCT00840320
Study groupRoleWhat they receive
1ExperimentalRepeat doses of active at escalating doses
Receives: Drug: 1278863
2Placebo comparatorRepeat doses of placebo
Receives: Drug: Placebo

What is being measured

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

  1. adverse events reporting

    Measured: throughout study

  2. Safety Labs (hematology)

    Measured: Screening, Days -1, 1-3, 5, 7, 9, 11, 14-18, 21, 25, 28

  3. vital signs (blood pressure and heart rate)

    Measured: Days 1-15, 28

  4. 12-lead ECG

    Measured: Screening, Days 1-2, 4, 6, 8, 10, 12, 14, 28

  5. dual-lead cardiac monitoring (telemetry monitoring)

    Measured: Days -1 to 3, 14

  6. clinical monitoring/observation

    Measured: throughout

  7. Safety Labs (Chemistry)

    Measured: Screening, Days -1, 1-3, 7, 10, 14-15, 17, 21, 28

  8. Safety Labs (Urinalysis)

    Measured: Screening, Days -1, 1-3, 7, 10, 14-15, 17, 21, 28

Secondary outcomes (9)

  1. AUC(0-∞) on Day 1, AUC(0-τ), Cmax, tmax and t1/2, on Days 1 and 14

    Measured: Days 1-2, 4, 6, 8, 10, 12, 14-18

  2. Trough plasma concentrations at the end of the dosing interval

    Measured: Days 2, 4, 6, 8, 10 and 12

  3. Hemoglobin actual values, rate of rise, maximum change from baseline, and rate of decline following stopping of dosing

    Measured: Days 1, 7, 14, 21, 28

  4. Fetal hemoglobin actual values, change from baseline, and percent of total hemoglobin

    Measured: Days 1, 7, 14, 21, 28

  5. Actual values and change from baseline in erythropoietin

    Measured: Days 1-4, 7, 14-15, 18, 21

  6. Actual values and change from baseline in absolute VEGF

    Measured: Days 1-2, 14-15, 18, 21

  7. Actual values and change from baseline in hepcidin

    Measured: Days 1-2, 7, 14-15, 18, 21

  8. Actual values and change from baseline in total iron binding capacity (TIBC)

    Measured: Screening, Days 1, 7, 14, 18, 21

  9. Actual values and change from baseline in transferring saturation (%)

    Measured: Days 1, 7, 14, 18, 21

Timeline

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

  1. First posted10 Feb 2009 (estimated)
  2. Study start13 Mar 2009
  3. Primary completion2 Sep 2009
  4. Study completion2 Sep 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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00840320
Sponsor's protocol ID
112842
Status last verified
Jun 2017
First submitted
9 Feb 2009
Last updated
22 Jun 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 1278863 in people with Kidney Disease, run by GlaxoSmithKline at 1 site in Australia.

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 32 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 22 Jun 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 Australia. 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?

adverse events reporting (time frame: throughout study). The study lists 8 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 NCT00840320.

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 22 Jun 2017.

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