CancerPhase 1NCT02040480
Bioavailability and Food Effect Study of Gelatin Formulation and Immediate Release Tablet Formulation of Afuresertib
A Phase 1 study testing GSK2110183 Gelatin Capsule and GSK2110183 IR Tablet in people with Cancer, run by GlaxoSmithKline at 1 site in Australia.
Trial summary
This study is being conducted to measure the relative bioavailability of the original gelatin capsule formulation and a new formulation, immediate release (IR) tablet of Afuresertib (GSK2110183). The study will be composed of Screening, Treatment, and Follow-up Periods. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- GSK2110183 Gelatin Capsule and GSK2110183 IR Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Feb 2014to 4 Apr 2014
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provided signed written informed consent
- Healthy Male or female between 18 and 40 years of age inclusive, at the time the informed consent is obtained.
- Body weight >=50 kilograms (kg) and body mass index (BMI) of >=18 and <= 32 kg/meter square (m^2).
- A female subject is eligible to participate if she is of (A) Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy or postmenopausal defined as 12 months of spontaneous amenorrhea (B) Child-bearing potential with negative pregnancy test as determined by serum human chorionic gonadotropin (hCG) test at Screening and prior to dosing, AND: agrees to use one of the acceptable contraception methods
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods.
- Alanine aminotransferase, alkaline phosphatase and bilirubin <=1.5xupper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Based on single or averaged QT interval corrected (QTc) values of triplicate ECGs obtained over a brief recording period: QTcB <450 millisecond (msec); or QTcB <480 msec in subjects with Bundle Branch Block.
- Able to swallow and retain orally administered study treatment and does not have any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
Who cannot join
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of gastroesophageal reflux disease, dyspepsia, peptic ulcer disease, gastrointestinal (GI) bleeding, GI surgery that could affect motility.
- History of atrial arrhythmias
- History of regular alcohol consumption within 6 months of the study defined as:
- An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 10 grams (g) of alcohol: 270 mL of full strength beer (4.8%), 375 mL of mid strength beer (3.5%), 470 mL of light beer (2.7%), 250 mL pre-mix full strength spirit (5%), 100mL of wine (13.5%) and 30 mL of spirit (40%).
- 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
Show all 17Show fewer
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of Screening.
- Smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- A positive drug/alcohol screen at Screening or upon check-in to the clinic on Day -1 of each Dosing Period.
- A positive test for human immuno virus (HIV) antibody.
- Pregnant females as determined by positive serum hCG test at Screening or prior to dosing.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Lactating females.
- 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.
- Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
- Any prohibited medications or recent consumption of citrus products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Open-Label, Sequential, Single Dose, 3-Period Crossover Study to Evaluate the Bioavailability and Food Effect of a Gelatin Formulation and Immediate Release Tablet Formulation of Afuresertib, an AKT Inhibitor, in Normal Healthy Volunteers
This study is being conducted to measure the relative bioavailability of the original gelatin capsule formulation and a new formulation, immediate release (IR) tablet of Afuresertib (GSK2110183). The study will be composed of Screening, Treatment, and Follow-up Periods. A subject's total time involved in the study will be approximately 9 weeks. The study will enroll approximately 18 healthy volunteers.
- Conditions
- Cancer
- Being tested
- GSK2110183 Gelatin Capsule, GSK2110183 IR Tablet
- Keywords
- bioavailability, food effect, formulation, GSK2110183, afuresertib, AKT inhibitor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2110183 Gelatin CapsuleDrug
White opaque hard gelatin capsule with a unit dose strength of 25 milligrams (mg) for oral administration
GSK2110183 IR TabletDrug
White round biconvex film coated IR tablet with a unit dose strength of 25 mg for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Participants will receive treatment in following sequence in each of the three study periods (one treatment per period): ABC Receives: Drug: GSK2110183 Gelatin Capsule; Drug: GSK2110183 IR Tablet |
| Sequence 2 | Experimental | Participants will receive treatment in following sequence in each of the three study periods (one treatment per period): ACB Receives: Drug: GSK2110183 Gelatin Capsule; Drug: GSK2110183 IR Tablet |
| Sequence 3 | Experimental | Participants will receive treatment in following sequence in each of the three study periods (one treatment per period): BAC Receives: Drug: GSK2110183 Gelatin Capsule; Drug: GSK2110183 IR Tablet |
| Sequence 4 | Experimental | Participants will receive treatment in following sequence in each of the three study periods (one treatment per period): BCA Receives: Drug: GSK2110183 Gelatin Capsule; Drug: GSK2110183 IR Tablet |
| Sequence 5 | Experimental | Participants will receive treatment in following sequence in each of the three study periods (one treatment per period): CAB Receives: Drug: GSK2110183 Gelatin Capsule; Drug: GSK2110183 IR Tablet |
| Sequence 6 | Experimental | Participants will receive treatment in following sequence in each of the three study periods (one treatment per period): CBA Receives: Drug: GSK2110183 Gelatin Capsule; Drug: GSK2110183 IR Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of pharmacokinetic (PK) parameters to determine relative bioavailability of afuresertib after administering it as a single dose in an original gelatin capsule in the fasted state and in a newly formulated IR tablet in the fed and fasted state.
PK parameters include: area under the plasma concentration-time curve from time zero to infinity (AUC [0-infinity]), area under the plasma concentration time curve from time zero to last time of quantifiable concentration (AUC [0-t]), maximum observed plasma concentration (Cmax), and time to Cmax (tmax).
Measured: PK Samples will be collected Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 120, and 168 hours post-dose
Secondary outcomes (6)
Number of subjects with adverse events (AEs).
AEs will be collected from the start of Study Treatment and until the Follow-up contact.
Measured: Up to 9 weeks
Clinical laboratory parameter assessment as a measure of safety and tolerability
Laboratory parameters include: hematology, clinical chemistry and urinalysis.
Measured: Up to 9 weeks
Concomitant medications review as a measure of safety and tolerability
Measured: Up to 9 weeks
Electrocardiogram (ECGs) measurement as a measure of safety and tolerability
Triplicate 12-lead ECGs will be collected at Screening; in each Dosing Period on Day 1 and Day 3 of Dosing Period; and at Follow-up.
Measured: Up to 9 weeks
Vital sign measurement as a measure of safety and tolerability
Vital sign measurements will include systolic and diastolic blood pressure and pulse rate.
Measured: Up to 9 weeks
Composite of PK parameter following single dose administration of IR tablet in fasted state
PK parameters include: AUC (0 - infinity), AUC (0 - t), Cmax, and tmax.
Measured: PK Samples will be collected Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 120, and 168 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study start5 Feb 2014
- Primary completion4 Apr 2014
- Study completion4 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040480
- Sponsor's protocol ID
- 201039
- Status last verified
- Nov 2017
- First submitted
- 16 Jan 2014
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Open-Label, Sequential, Single Dose, 3-Period Crossover Study to Evaluate the Bioavailability and Food Effect of a Gelatin Formulation and Immediate Release Tablet Formulation of Afuresertib, an AKT Inhibitor, in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02040480
- Acronym / sponsor ID
- 201039
- Conditions
- Cancer
- Keywords
- bioavailability, food effect, formulation, GSK2110183, afuresertib, AKT inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2014 (actual)
- Primary completion
- 4 Apr 2014 (actual)
- Study completion
- 4 Apr 2014 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to measure the relative bioavailability of the original gelatin capsule formulation and a new formulation, immediate release (IR) tablet of Afuresertib (GSK2110183). The study will be composed of Screening, Treatment, and Follow-up Periods. A subject's total time involved in the study will be approximately 9 weeks. The study will enroll approximately 18 healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: GSK2110183 Gelatin Capsule, Drug: GSK2110183 IR TabletParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): ABC |
| Sequence 2 | Experimental | Drug: GSK2110183 Gelatin Capsule, Drug: GSK2110183 IR TabletParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): ACB |
| Sequence 3 | Experimental | Drug: GSK2110183 Gelatin Capsule, Drug: GSK2110183 IR TabletParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): BAC |
| Sequence 4 | Experimental | Drug: GSK2110183 Gelatin Capsule, Drug: GSK2110183 IR TabletParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): BCA |
| Sequence 5 | Experimental | Drug: GSK2110183 Gelatin Capsule, Drug: GSK2110183 IR TabletParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): CAB |
| Sequence 6 | Experimental | Drug: GSK2110183 Gelatin Capsule, Drug: GSK2110183 IR TabletParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): CBA |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Provided signed written informed consent
- Healthy Male or female between 18 and 40 years of age inclusive, at the time the informed consent is obtained.
- Body weight >=50 kilograms (kg) and body mass index (BMI) of >=18 and <= 32 kg/meter square (m^2).
- A female subject is eligible to participate if she is of (A) Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy or postmenopausal defined as 12 months of spontaneous amenorrhea (B) Child-bearing potential with negative pregnancy test as determined by serum human chorionic gonadotropin (hCG) test at Screening and prior to dosing, AND: agrees to use one of the acceptable contraception methods
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods.
Key exclusion criteria (17 listed)
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of gastroesophageal reflux disease, dyspepsia, peptic ulcer disease, gastrointestinal (GI) bleeding, GI surgery that could affect motility.
- History of atrial arrhythmias
- History of regular alcohol consumption within 6 months of the study defined as:
- An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 10 grams (g) of alcohol: 270 mL of full strength beer (4.8%), 375 mL of mid strength beer (3.5%), 470 mL of light beer (2.7%), 250 mL pre-mix full strength spirit (5%), 100mL of wine (13.5%) and 30 mL of spirit (40%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK2110183 Gelatin CapsuleWhite opaque hard gelatin capsule with a unit dose strength of 25 milligrams (mg) for oral administration | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| GSK2110183 IR TabletWhite round biconvex film coated IR tablet with a unit dose strength of 25 mg for oral administration | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Composite of pharmacokinetic (PK) parameters to determine relative bioavailability of afuresertib after administering it as a single dose in an original gelatin capsule in the fasted state and in a newly formulated IR tablet in the fed and fasted state.
Time frame: PK Samples will be collected Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 120, and 168 hours post-dose
PK parameters include: area under the plasma concentration-time curve from time zero to infinity (AUC [0-infinity]), area under the plasma concentration time curve from time zero to last time of quantifiable concentration (AUC [0-t]), maximum observed plasma concentration (Cmax), and time to Cmax (tmax).
6 secondary outcomes
Number of subjects with adverse events (AEs).
Time frame: Up to 9 weeks
Clinical laboratory parameter assessment as a measure of safety and tolerability
Time frame: Up to 9 weeks
Concomitant medications review as a measure of safety and tolerability
Time frame: Up to 9 weeks
Electrocardiogram (ECGs) measurement as a measure of safety and tolerability
Time frame: Up to 9 weeks
Vital sign measurement as a measure of safety and tolerability
Time frame: Up to 9 weeks
Composite of PK parameter following single dose administration of IR tablet in fasted state
Time frame: PK Samples will be collected Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 120, and 168 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Results for study 201039 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK2110183 Gelatin Capsule and GSK2110183 IR Tablet in people with Cancer, 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 8 inclusion and 17 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 13 Nov 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. 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?
Composite of pharmacokinetic (PK) parameters to determine relative bioavailability of afuresertib after administering it as a single dose in an original gelatin capsule in the fasted state and in a newly formulated IR tablet in the fed and fasted state. (time frame: PK Samples will be collected Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 120, and 168 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2017; AzTrials last refreshed its copy on 6 Nov 2026.