CancerPhase 1NCT01827644

Bioavailability and Food Effect of the Original Gelatin Formulation and Two New Formulations of Afuresertib in Normal Healthy Volunteers

A Phase 1 study testing Afuresertib GC - Fasted State, Afuresertib HPMC capsule - Fasted State and Afuresertib ECT - Fasted State in people with Cancer, 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

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Cancer
What is being tested?: Afuresertib GC - Fasted State, Afuresertib HPMC capsule - Fasted State and Afuresertib ECT - Fasted State
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteAustralia
Study dates: 24 Apr 2013to 12 Jul 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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
Male or female between 18 and 40 years of age inclusive, at the time of signing the informed consent
Body weight >=50 kilograms (kg) and body mass index (BMI) <=32 kg/m^2 (square meter)
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 acceptable contraception methods.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5 x Upper Limit of Normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Based on single or averaged corrected QT interval (QTc) values of triplicate electrocardiograms (ECGs) obtained over a brief recording period: QTc <450 milliseconds (msec) or QTc <480 msec in subjects with Bundle Branch Block

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 (GERD), dyspepsia, 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 8 grams (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
History of sensitivity to heparin or heparin-induced thrombocytopenia
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 18Show fewer

Use of prescription or non-prescription medications, vitamins, and dietary or herbal supplements (including St John's Wort) within 7 days (or 14 days if the drug/supplement is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study drug until completion of the Follow-up Period, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study
Unable to abstain from smoking tobacco or the use of nicotine-containing products while admitted to the clinic
Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of Study Drug on Day 1 of Dosing Period 1, until completion of the Follow-up Period
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of Screening
History of heavy 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 Immunodeficiency 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

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 Single Center, Randomized, Open-Label, Sequential, Single Dose, 4-Period Crossover Study to Evaluate the Bioavailability and Food Effect of a Gelatin Formulation and Two Prototype Formulations of Afuresertib, an AKT Inhibitor, in Normal Healthy Volunteers

This will be a randomized, open-label, sequential, single dose, 4-period crossover study. This study is being conducted to measure the relative bioavailability of the original gelatin capsule (GC) formulation and two new formulations (hydroxypropyl-methylcellulose [HPMC] capsule and enteric coated tablet [ECT]) of afuresertib (AFU), in the fed and fasted state. The study will be composed of Screening, Treatment, and Follow-up Periods. Screening assessments to determine subject eligibility will be performed within 3 weeks prior to the first dose of study drug in the Treatment Period. Eligible subjects will be randomized to receive 4 of the 6 possible study treatments (A: AFU GC administered in a fasted state, B: AFU GC administered in a fed state, C: AFU HPMC capsule administered in a fasted state, D: AFU HPMC capsule administered in a fed state, E: AFU ECT administered in a fasted state, F: AFU ECT administered in a fed state) in 4 treatment periods (one per treatment period). Subjects will receive a single dose of one of the six study treatments (A, B, C, D, E, F) on Day 1 of each Dosing Period, according to one of the 6 treatment sequences (CEDA, EFAB, ABFC, BDCE, FCBD, DAEF). There will be a minimum of 10 Day washout period between the doses administered in each Treatment Period. A Follow-up visit will be conducted within 10-14 days after the last dose. A subject's total time involved in the study will be approximately 9 weeks. At least 36 subjects will be enrolled in the study, to ensure that at least 6 subjects will be randomized to receive each treatment sequence.

Conditions: Cancer
Being tested: Afuresertib GC - Fasted State, Afuresertib HPMC capsule - Fasted State, Afuresertib ECT - Fasted State, Afuresertib GC - Fed State, Afuresertib HPMC capsule - Fed State
Keywords: AKT inhibitor, formulation, food effect, bioavailability, GSK2110183
Medical subject headings: Neoplasms

What participants receive

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

Afuresertib GC - Fasted StateDrug
White opaque hard gelatin capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib GC administered in fasted state
Afuresertib HPMC capsule - Fasted StateDrug
White opaque HPMC capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib HPMC capsule administered in fasted state
Afuresertib ECT - Fasted StateDrug
White to off white, round, biconvex coated tablet containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib ECT administered in fasted state
Afuresertib GC - Fed StateDrug
White opaque hard gelatin capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib GC administered in fed state
Afuresertib HPMC capsule - Fed StateDrug
White opaque HPMC capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib HPMC capsule administered in fed state
Afuresertib ECT - Fed StateDrug
White to off white, round, biconvex coated tablet containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib ECT administered in fed state

Study groups in NCT01827644
Study group	Role	What they receive
Sequence 1	Experimental	Subjects will receive single doses of AFU HPMC capsule administered in a fasted state, AFU ECT administered in a fasted state, AFU HPMC capsule administered in a fed state and AFU GC administered in a fasted state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period Receives: Drug: Afuresertib GC - Fasted State; Drug: Afuresertib HPMC capsule - Fasted State; Drug: Afuresertib ECT - Fasted State; Drug: Afuresertib HPMC capsule - Fed State
Sequence 2	Experimental	Subjects will receive single doses of AFU ECT administered in a fasted state, AFU ECT administered in a fed state, AFU GC administered in a fasted state and AFU GC administered in a fed state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period. Receives: Drug: Afuresertib GC - Fasted State; Drug: Afuresertib ECT - Fasted State; Drug: Afuresertib GC - Fed State; Drug: Afuresertib ECT - Fed State
Sequence 3	Experimental	Subjects will receive single doses of AFU GC administered in a fasted state, AFU GC administered in a fed state, AFU ECT administered in a fed state and AFU HPMC capsule administered in a fasted state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period. Receives: Drug: Afuresertib GC - Fasted State; Drug: Afuresertib HPMC capsule - Fasted State; Drug: Afuresertib GC - Fed State; Drug: Afuresertib ECT - Fed State
Sequence 4	Experimental	Subjects will receive single doses of AFU GC administered in a fed state, AFU HPMC capsule administered in a fed state, AFU HPMC capsule administered in a fasted state and AFU ECT administered in a fasted state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period Receives: Drug: Afuresertib HPMC capsule - Fasted State; Drug: Afuresertib ECT - Fasted State; Drug: Afuresertib GC - Fed State; Drug: Afuresertib HPMC capsule - Fed State
Sequence 5	Experimental	Subjects will receive single doses of AFU ECT administered in a fed state, AFU HPMC capsule administered in a fasted state, AFU GC administered in a fed state and AFU HPMC capsule administered in a fed state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period Receives: Drug: Afuresertib HPMC capsule - Fasted State; Drug: Afuresertib GC - Fed State; Drug: Afuresertib HPMC capsule - Fed State; Drug: Afuresertib ECT - Fed State
Sequence 6	Experimental	Subjects will receive single doses of AFU HPMC capsule administered in a fed state, AFU GC administered in a fasted state, AFU ECT administered in a fasted state and AFU ECT administered in a fed state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period Receives: Drug: Afuresertib GC - Fasted State; Drug: Afuresertib ECT - Fasted State; Drug: Afuresertib HPMC capsule - Fed State; Drug: Afuresertib ECT - Fed State

What is being measured

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

Composite of plasma pharmacokinetics (PK) parameters of afuresertib, following administration with and without food
Relative bioavailability of afuresertib after single dose of a GC, HPMC capsule and ECT, with and without high fat/calorie meal, will be determined by the following PK parameters: Area under the plasma concentration time curve- from time zero (pre-dose) to infinite time [AUC(0-inf)] and from time zero (pre-dose) to last time of quantifiable concentration [AUC(0-t)], maximum observed plasma concentration (Cmax), time to Cmax (tmax), observed plasma concentration at 24 hours (C24), and minimal observed plasma concentration (Ct)
Measured: PK samples will be collected at Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours post-dose in each dosing period

Secondary outcomes (6)

Safety and tolerability of afuresertib as assessed by 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
Safety and tolerability of afuresertib as assessed by clinical laboratory tests
Hematology, clinical chemistry and urinalysis parameters will be measured
Measured: Up to 9 weeks
Safety and tolerability of afuresertib as assessed by concomitant medications review
Measured: Up to 9 weeks
Safety and tolerability of afuresertib as assessed by electrocardiograms (ECG) measurements
Triplicate 12-lead ECGs will be collected at Screening; on Day 1 and Day 3 of each Dosing Period; and at Follow-up
Measured: Up to 9 weeks
Safety and tolerability of afuresertib as assessed by vital signs measurement
Vital sign measurements will include systolic and diastolic blood pressure and pulse rate
Measured: Up to 9 weeks
Change in phosphoAKT (pAKT) levels in peripheral blood samples following administration of a gelatin capsule, HPMC capsule and ECT
The potential relationship between plasma PK and pharmacodynamic biomarker changes (pAKT) of each formulation will be evaluated
Measured: Pre-dose and 2, 12, and 24 hours post-dose in each dosing period.

Timeline

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

24 Apr 201312 Jul 2013

First posted9 Apr 2013 (estimated)
Study start24 Apr 2013
Primary completion12 Jul 2013
Study completion12 Jul 2013

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: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01827644
Sponsor's protocol ID: 117313
Status last verified: Nov 2017
First submitted: 5 Apr 2013
Last updated: 13 Nov 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Cancer trials

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, 4-Period Crossover Study to Evaluate the Bioavailability and Food Effect of a Gelatin Formulation and Two Prototype Formulations of Afuresertib, an AKT Inhibitor, in Normal Healthy Volunteers
ClinicalTrials.gov ID: NCT01827644
Acronym / sponsor ID: 117313
Conditions: Cancer
Keywords: AKT inhibitor, formulation, food effect, bioavailability, GSK2110183
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 24 Apr 2013 (actual)
Primary completion: 12 Jul 2013 (actual)
Study completion: 12 Jul 2013 (actual)
First posted: 9 Apr 2013 (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.

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: Afuresertib GC - Fasted State, Drug: Afuresertib HPMC capsule - Fasted State, Drug: Afuresertib ECT - Fasted State, Drug: Afuresertib HPMC capsule - Fed StateSubjects will receive single doses of AFU HPMC capsule administered in a fasted state, AFU ECT administered in a fasted state, AFU HPMC capsule administered in a fed state and AFU GC administered in a fasted state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period
Sequence 2	Experimental	Drug: Afuresertib GC - Fasted State, Drug: Afuresertib ECT - Fasted State, Drug: Afuresertib GC - Fed State, Drug: Afuresertib ECT - Fed StateSubjects will receive single doses of AFU ECT administered in a fasted state, AFU ECT administered in a fed state, AFU GC administered in a fasted state and AFU GC administered in a fed state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period.
Sequence 3	Experimental	Drug: Afuresertib GC - Fasted State, Drug: Afuresertib HPMC capsule - Fasted State, Drug: Afuresertib GC - Fed State, Drug: Afuresertib ECT - Fed StateSubjects will receive single doses of AFU GC administered in a fasted state, AFU GC administered in a fed state, AFU ECT administered in a fed state and AFU HPMC capsule administered in a fasted state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period.
Sequence 4	Experimental	Drug: Afuresertib HPMC capsule - Fasted State, Drug: Afuresertib ECT - Fasted State, Drug: Afuresertib GC - Fed State, Drug: Afuresertib HPMC capsule - Fed StateSubjects will receive single doses of AFU GC administered in a fed state, AFU HPMC capsule administered in a fed state, AFU HPMC capsule administered in a fasted state and AFU ECT administered in a fasted state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period
Sequence 5	Experimental	Drug: Afuresertib HPMC capsule - Fasted State, Drug: Afuresertib GC - Fed State, Drug: Afuresertib HPMC capsule - Fed State, Drug: Afuresertib ECT - Fed StateSubjects will receive single doses of AFU ECT administered in a fed state, AFU HPMC capsule administered in a fasted state, AFU GC administered in a fed state and AFU HPMC capsule administered in a fed state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period
Sequence 6	Experimental	Drug: Afuresertib GC - Fasted State, Drug: Afuresertib ECT - Fasted State, Drug: Afuresertib HPMC capsule - Fed State, Drug: Afuresertib ECT - Fed StateSubjects will receive single doses of AFU HPMC capsule administered in a fed state, AFU GC administered in a fasted state, AFU ECT administered in a fasted state and AFU ECT administered in a fed state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
Male or female between 18 and 40 years of age inclusive, at the time of signing the informed consent
Body weight >=50 kilograms (kg) and body mass index (BMI) <=32 kg/m^2 (square meter)
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 acceptable contraception methods.

Key exclusion criteria (18 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 (GERD), dyspepsia, 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 8 grams (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
History of sensitivity to heparin or heparin-induced thrombocytopenia

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
Afuresertib GC - Fasted StateWhite opaque hard gelatin capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib GC administered in fasted state	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 6
Afuresertib HPMC capsule - Fasted StateWhite opaque HPMC capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib HPMC capsule administered in fasted state	Drug	Sequence 1, Sequence 3, Sequence 4, Sequence 5
Afuresertib ECT - Fasted StateWhite to off white, round, biconvex coated tablet containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib ECT administered in fasted state	Drug	Sequence 1, Sequence 2, Sequence 4, Sequence 6
Afuresertib GC - Fed StateWhite opaque hard gelatin capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib GC administered in fed state	Drug	Sequence 2, Sequence 3, Sequence 4, Sequence 5
Afuresertib HPMC capsule - Fed StateWhite opaque HPMC capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib HPMC capsule administered in fed state	Drug	Sequence 1, Sequence 4, Sequence 5, Sequence 6
Afuresertib ECT - Fed StateWhite to off white, round, biconvex coated tablet containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib ECT administered in fed state	Drug	Sequence 2, Sequence 3, Sequence 5, Sequence 6

Primary outcome

Composite of plasma pharmacokinetics (PK) parameters of afuresertib, following administration with and without food
Time frame: PK samples will be collected at Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours post-dose in each dosing period
Relative bioavailability of afuresertib after single dose of a GC, HPMC capsule and ECT, with and without high fat/calorie meal, will be determined by the following PK parameters: Area under the plasma concentration time curve- from time zero (pre-dose) to infinite time [AUC(0-inf)] and from time zero (pre-dose) to last time of quantifiable concentration [AUC(0-t)], maximum observed plasma concentration (Cmax), time to Cmax (tmax), observed plasma concentration at 24 hours (C24), and minimal observed plasma concentration (Ct)

6 secondary outcomes

Safety and tolerability of afuresertib as assessed by number of subjects with adverse events (AEs)
Time frame: Up to 9 weeks
Safety and tolerability of afuresertib as assessed by clinical laboratory tests
Time frame: Up to 9 weeks
Safety and tolerability of afuresertib as assessed by concomitant medications review
Time frame: Up to 9 weeks
Safety and tolerability of afuresertib as assessed by electrocardiograms (ECG) measurements
Time frame: Up to 9 weeks
Safety and tolerability of afuresertib as assessed by vital signs measurement
Time frame: Up to 9 weeks
Change in phosphoAKT (pAKT) levels in peripheral blood samples following administration of a gelatin capsule, HPMC capsule and ECT
Time frame: Pre-dose and 2, 12, and 24 hours post-dose in each dosing period.

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 117313 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 Afuresertib GC - Fasted State, Afuresertib HPMC capsule - Fasted State and Afuresertib ECT - Fasted State 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 18 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 plasma pharmacokinetics (PK) parameters of afuresertib, following administration with and without food (time frame: PK samples will be collected at Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours post-dose in each dosing period). 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 NCT01827644.

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.