AzTrials
AzTrials

Alzheimer's DiseasePhase 1NCT01702467

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single, Oral Escalating Doses of GSK2647544 in Healthy Volunteers

A Phase 1 study testing GSK2647544 in people with Alzheimer's 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
Search all trials

Trial summary

The current study will examine the safety, tolerability, plasma pharmacokinetics (PK), and plasma pharmacodynamics (PD) of single-doses of GSK2647544.The study will be conducted as a randomized, single-blind, placebo controlled, 4-way crossover single oral ascending dose design in 2 independent cohorts, eight healthy… Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Alzheimer's Disease
What is being tested?
GSK2647544
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
27 participants
Where
1 siteAustralia
Study dates
19 Oct 2012to 15 May 2013
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males who are 18 to 55 years of age, inclusive
  • Healthy as determined by a responsible and experienced physician
  • aspartate aminotransferase (AST), Alanine transaminase (ALT), alkaline phosphatase and bilirubin <= 1.5xUpper Limit of Normal (ULN)
  • Average of triplicate QTcB values and average of triplicate QTcF values must both < 450 millisecond (msec)
  • Body weight > 50 kg (110 pounds) and body mass index (BMI) between 19 and 30
  • Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods
  • Capable of giving written informed consent

Who cannot join

  • Those with Lp-PLA2 activity <=20 nanomole/minute/milliliter (mL)(for subjects with 2 known birth parents of at least 50% Japanese, Chinese, or Korean ancestry)
  • History of asthma, anaphylaxis or anaphalactoid reactions, severe allergic responses
  • History of hypercoagulable state or history of thrombosis
  • A history of biliary tract disease including a history of liver disease with elevated liver function tests of known or unknown etiology
  • Positive Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C at screening
  • History of regular use of tobacco- or nicotine-containing products within three months of the study and/or has a positive breath CO at screening
Show all 16Show fewer
  • History of alcohol consumption exceeding, on average, 21 drinks/week for men (1 drink = 100 mL of wine or 240 mL of beer or 30 mL of hard liquor in Australia) within 6 months of the first dose of study medication
  • Positive urine drug or positive breath alcohol test at screening or at admission to Clinical Research Unit
  • Unable to refrain from use of prescription or non-prescription drugs and vitamins within 7 days or 5 half-lives (whichever is longer) prior to administration of study
  • Unable to refrain from use of dietary/herbal supplements including (but not limited to) St. John's wort, kava, ephedra (ma huang), gingko biloba, DHEA, yohimbe, saw palmetto, ginseng and red yeast rice within 14 days prior to treatment with study medication
  • Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to dosing
  • Unable to refrain from consumption of grapefruit or grapefruit juice within 7 days prior to the first dose of study medication
  • For male subjects, an unwillingness to abstain from sexual intercourse with pregnant or lactating women or an unwillingness to use a condom plus partner use of a highly effective contraceptive if engaging in sexual intercourse with a woman who could become pregnant until discharge from the study
  • Donation of blood in excess of 500 mL within 56 days prior to dosing
  • History of sensitivity to heparin or heparin-induced thrombocytopenia
  • Subjects, who in the investigator's judgement, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behaviour and/or any suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • GSK Investigational Site

    Randwick, New South Wales, 2031

Other trials in Australia

About this study

Official title: A Single-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single, Oral Escalating Doses of GSK2647544 in Healthy Volunteers

The current study will examine the safety, tolerability, plasma pharmacokinetics (PK), and plasma pharmacodynamics (PD) of single-doses of GSK2647544.The study will be conducted as a randomized, single-blind, placebo controlled, 4-way crossover single oral ascending dose design in 2 independent cohorts, eight healthy male subjects in each of the cohorts. Each potential subject will undergo Screening visit, Treatment Phase and Follow-up visit.

Being tested
GSK2647544, Placebo
Keywords
Lp-PLA2, Alzheimer's disease
Medical subject headings
Alzheimer Disease

What participants receive

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

  • GSK2647544Drug

    Capsules containing 0.5mg to 50mg of GSK2647544.

  • PlaceboDrug

    Matching placebo capsules.

Study groups in NCT01702467
Study groupRoleWhat they receive
GSK2647544ExperimentalThe starting dose of GSK2647544 is 0.5 mg. The escalating doses to be administered will be determined based on study results from previous dose (s).
Receives: Drug: GSK2647544
PlaceboPlacebo comparatorMatching placebo
Receives: Drug: Placebo

What is being measured

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

  1. Safety and tolerability of GSK2647544 as assessed by number of subjects with adverse events (AE)s

    Safety and tolerability parameters will include recording of AEs

    Measured: 5 days in each of the 4 dosing session

  2. Safety and tolerability of GSK2647544 as assessed by change from Baseline in laboratory values

    Safety and tolerability parameters will include laboratory (haematology, clinical chemistry, urinalysis) values at Screening, Day -1, Day 3 and Follow-up (7-14 days post-last dose)

    Measured: 5 days in each of the 4 dosing session

  3. Safety and tolerability of GSK2647544 as assessed by change from Baseline in ECG readings

    Safety and tolerability parameter will include the electrocardiogram (ECG) readings at Screening, Day -1, Day 1, Day 2, Day 3 and Follow-up (7-14 days post-last dose)

    Measured: 5 days in each of the 4 dosing session

  4. Safety and tolerability of GSK2647544 as assessed by change from Baseline in Telemetry ECG parameters

    Safety and tolerability parameter will include the Telemetry ECG readings from 30 minutes pre-dosing till 48 hours post-dosing

    Measured: 3 Days in each of the 4 dosing session

  5. Safety and tolerability of GSK2647544 as assessed by change from Baseline in vital signs

    Vital signs measurement include systolic and diastolic blood pressure and pulse rate at Screening, Day -1, Day 1, Day 2, Day 3, Day 4 and Follow-up (7-14 days post-last dose)

    Measured: 5 days in each of the 4 dosing session

  6. Safety and tolerability of GSK2647544 as assessed by using the Columbia Suicide Severity Rating Scale (C-SSRS)

    C-SSRS will be measured at Screening, Day -1, Day 1 (conducted prior to discharge) and Follow-up (7-14 days post-last dose)

    Measured: 5 days in each of the 4 dosing session

Secondary outcomes (6)

  1. Peak plasma concentration (Cmax) of GSK2647544

    To assess PK profile of GSK2647544, Cmax of GSK2647544 will be measured

    Measured: 4 Days in each of the 4 dosing session

  2. Time of peak plasma concentration (tmax) of GSK2647544

    To assess PK profile of GSK2647544 tmax of GSK2647544 will be measured

    Measured: 4 Days in each of the 4 dosing session

  3. Area under the time concentration curve (AUC) of GSK2647544

    To assess PK profile of GSK2647544 AUC of GSK2647544 will be measured

    Measured: 4 Days in each of the 4 dosing session

  4. Terminal half-life (t½ ) of GSK2647544

    To assess PK profile of GSK2647544 t½ of GSK2647544 will be measured

    Measured: 4 Days in each of the 4 dosing session

  5. Apparent oral clearance (CL/F) of GSK2647544

    To assess PK profile of GSK2647544 CL/F of GSK2647544 will be measured

    Measured: 4 Days in each of the 4 dosing session

  6. Predose plasma lipoprotein-associated phospholipase A2 (Lp-PLA2) activity and postdose Lp-PLA2 activity

    It will be measured at Day 1, Day 2, Day 3, Day 4 and Day 5

    Measured: 5 Days in each of the 4 dosing session

Timeline

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

  1. First posted8 Oct 2012 (estimated)
  2. Study start19 Oct 2012
  3. Primary completion15 May 2013
  4. Study completion15 May 2013

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
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01702467
Sponsor's protocol ID
116698
Status last verified
Oct 2017
First submitted
4 Oct 2012
Last updated
18 Oct 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 GSK2647544 in people with Alzheimer's 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 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 18 Oct 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?

Safety and tolerability of GSK2647544 as assessed by number of subjects with adverse events (AE)s (time frame: 5 days in each of the 4 dosing session). The study lists 6 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 NCT01702467.

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 18 Oct 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in