Infection, Human Immunodeficiency VirusPhase 1NCT02345707
Relative Bioavailability Study of Phase III Tablet Formulation of Cabotegravir
A Phase 1 study testing Cabotegravir 30 mg current formulation, Cabotegravir 30 mg micronized new formulation 500 M and Cabotegravir 30 mg unmicronized new formulation 500 U in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United States.
Trial summary
This study is a single-center, randomized, open-label, two cohorts, 3-way cross-over design in 36 subjects to assess the oral bioavailability of four new cabotegravir (CAB) sodium salt tablet formulations relative to the current CAB sodium salt formulation being used in the phase IIb studies under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- What is being tested?
- Cabotegravir 30 mg current formulation, Cabotegravir 30 mg micronized new formulation 500 M and Cabotegravir 30 mg unmicronized new formulation 500 U
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jun 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Body weight >=50 kilogram (kg) and body mass index (BMI) within the range 18.5 -31.0 kg/ meter square (m^2) (inclusive).
- Male or Female
- Female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test), not lactating, and at least one of the following conditions applies: a) Non-reproductive potential defined as: Pre-menopausal females with one of the following [for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records]: Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy. b) Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause >40 milli-International Units (MIU)/ milliliter (mL) and estradiol <40 picogram (pg)/mL (<147 picomole [pmol]/ liter [L]) is confirmatory]. c) Reproductive potential and agrees to follow one of the options listed below in the GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until after the last dose of study medication and completion of the follow-up visit. GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in FRP are as follows. This list does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis. a) Intrauterine device or intrauterine system that meets the standard operating procedure (SOP) effectiveness criteria including a <1% rate of failure per year, as stated in the product label. b) Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. c) Male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository) only for the following 3 situations when there is a very low risk for developmental toxicity: Vaccines; Monoclonal antibodies when there is no target biology concern; Compounds that have a complete reproductive toxicology package and have not shown any signal for developmental toxicity. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. Sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
- Alanine transaminase (ALT), alkaline phosphatase and bilirubin <=1.5x Upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
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 clinically significant cardiovascular disease including: a) Exclusion criteria for screening Electrocardiogram (ECG) (a single repeat is allowed for eligibility determination) Heart rate: Males: <45 and >100 beats per minute, Females: <50 and >100 beats per minute; QRS duration: >120 millisecond (msec), QTc interval (B): >450 msec; b) Evidence of previous myocardial infarction (pathologic Q waves, S-T segment changes (except early repolarization). c) History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PCTA) or any clinically significant cardiac disease. d) Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular block (AV) block [2nd degree (type II) or higher], Wolf Parkinson White [WPW] syndrome). e) Sinus pauses >3 seconds. f) Any significant arrhythmia which, in the opinion of the principal Investigator and GSK Medical Monitor, will interfere with the safety for the individual subject. g) Non-sustained (>=3 consecutive ventricular ectopic beats) or sustained ventricular tachycardia. NOTES: The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read. The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial. For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used as specified in the Reporting and Analysis Plan (RAP).
- Concomitant medications that are prohibited for this study.
- History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams (g) of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- 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 Medical Monitor, contraindicates their participation.
- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. Hepatitis B core antibody (HBcAb) with negative hepatitis b surface antibody should also be excluded.
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- A positive pre-study drug/alcohol screen.
- A positive test for Human Immunodeficiency Virus (HIV) antibody.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- The subject's systolic blood pressure is outside the range of 90-140 millimeters of mercury (mmHg), or diastolic blood pressure is outside the range of 45-90 mmHg.
- 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.
United States1 site
GSK Investigational Site
Overland Park, Kansas, 66211
About this study
Official title: A Phase 1, Single-center, Randomized, Open-label, Crossover Study to Assess the Relative Bioavailability of Phase III Tablet Formulation Candidates in Healthy Adult Subjects
This study is a single-center, randomized, open-label, two cohorts, 3-way cross-over design in 36 subjects to assess the oral bioavailability of four new cabotegravir (CAB) sodium salt tablet formulations relative to the current CAB sodium salt formulation being used in the phase IIb studies under fasting conditions. All treatments will be administered as single 30 mg doses of CAB. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 10 - 14 days after the last dose of study drug. Treatment period doses will be separated by a 14 day washout. Participation in this study will be approximately 12 weeks.
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- Cabotegravir 30 mg current formulation, Cabotegravir 30 mg micronized new formulation 500 M, Cabotegravir 30 mg unmicronized new formulation 500 U, Cabotegravir 30 mg micronized new formulation 650 M, Cabotegravir 30 mg unmicronized new formulation 650 U
- Keywords
- Cabotegravir, Human Immunodeficiency Virus, Bioavailability, Pharmacokinetics
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabotegravir 30 mg current formulationDrug
Cabotegravir 30 mg current formulation (Treatment A) is a film coated tablet with a weight of 824 mg
Cabotegravir 30 mg micronized new formulation 500 MDrug
Cabotegravir 30 mg micronized new formulation 500 M (Treatment B) is a film coated tablet with a weight of 515 mg
Cabotegravir 30 mg unmicronized new formulation 500 UDrug
Cabotegravir 30 mg unmicronized new formulation 500 U (Treatment C) is a film coated tablet with a weight of 515 mg
Cabotegravir 30 mg micronized new formulation 650 MDrug
Cabotegravir 30 mg micronized new formulation 650 M (Treatment D) is a film coated tablet with a weight of 670 mg
Cabotegravir 30 mg unmicronized new formulation 650 UDrug
Cabotegravir 30 mg unmicronized new formulation 650 U (Treatment E) is a film coated tablet with a weight of 670 mg
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Subjects will receive reference cabotegravir 30 mg current formulation (Treatment A), Cabotegravir 30 mg micronized new formulation 500 M (Treatment B) and Cabotegravir 30 mg unmicronized new formulation 500 U (Treatment C) in one of six sequences ABC, ACB, BCA, BAC, CAB, CBA in three treatment periods under fasting condition Receives: Drug: Cabotegravir 30 mg current formulation; Drug: Cabotegravir 30 mg micronized new formulation 500 M; Drug: Cabotegravir 30 mg unmicronized new formulation 500 U |
| Part B | Experimental | Subjects will receive reference Cabotegravir 30 mg current formulation (Treatment A), Cabotegravir 30 mg micronized new formulation 650 M (Treatment D) and Cabotegravir 30 mg unmicronized new formulation 650 U (Treatment E) in one of six sequences ADE, AED, DAE, DEA, EAD, EDA in three treatment periods under fasting condition Receives: Drug: Cabotegravir 30 mg current formulation; Drug: Cabotegravir 30 mg micronized new formulation 650 M; Drug: Cabotegravir 30 mg unmicronized new formulation 650 U |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of pharmacokinetic (PK) parameters for cabotegravir evaluated by measurement of plasma AUC (0-infinity), AUC (0-t) and Cmax and C24
To evaluate the relative bioavailability of cabotegravir after single 30 mg dose in the fasted state, the following PK parameters will be assessed: area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)), area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments (AUC (0-t)), maximum observed concentration (Cmax) and concentration at 24 hours post-dose (C24)
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post dose.
Secondary outcomes (6)
Composite of PK parameters for cabotegravir evaluated by measurement of plasma t1/2, tlag, tmax, %AUCex, AUC (0-72), and CL/F
Other plasma PK parameters of cabotegravir from new formulations that will be compared to the current formulation are the following:terminal phase half-life (t ½) , lag time before observation of drug concentrations in sampled matrix (tlag), time of occurrence of Cmax (tmax), percentage of AUC(0-infinity) obtained by extrapolation (%AUCex), area under the concentration-time curve from time zero to 72 hours post dose (AUC (0-72), time of last measurable concentration (tlast) and apparent clearance following oral dosing (CL/F) after single 30 mg dose in the fasted state
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post dose.
Number of participants with adverse events as a measure of safety and tolerability of Cabotegravir
Safety and tolerability of cabotegravir will be assessed by clinical safety data from number of participants with adverse event. Adverse events will be collected from the start of study treatment and until the final follow-up visit. Intensity of AEs will be categorized as mild, moderate or severe.
Measured: Up to 8 weeks
Safety and tolerability of single oral dose of Cabotegravir assessed by concurrent medication used any time during the study period along with the study medication.
Measured: Up to 8 weeks
Safety and tolerability of single oral dose of Cabotegravir assessed by clinical laboratory screens
Safety laboratory tests will include hematology, clinical chemistry and additional parameters
Measured: Up to 8 weeks
Safety and tolerability of single oral dose of Cabotegravir assessed by12-lead electrocardiogram
Measured: Up to 8 weeks
Safety and tolerability of single oral dose of Cabotegravir assessed by vital signs
Vital signs will include systolic and diastolic blood pressure and pulse rate.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345707
- Sponsor's protocol ID
- 201741
- Status last verified
- Jun 2015
- First submitted
- 19 Jan 2015
- Last updated
- 13 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Randomized, Open-label, Crossover Study to Assess the Relative Bioavailability of Phase III Tablet Formulation Candidates in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02345707
- Acronym / sponsor ID
- 201741
- Conditions
- Infection, Human Immunodeficiency Virus
- Keywords
- Cabotegravir, Human Immunodeficiency Virus, Bioavailability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Jan 2015 (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 a single-center, randomized, open-label, two cohorts, 3-way cross-over design in 36 subjects to assess the oral bioavailability of four new cabotegravir (CAB) sodium salt tablet formulations relative to the current CAB sodium salt formulation being used in the phase IIb studies under fasting conditions. All treatments will be administered as single 30 mg doses of CAB. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 10 - 14 days after the last dose of study drug. Treatment period doses will be separated by a 14 day washout. Participation in this study will be approximately 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Cabotegravir 30 mg current formulation, Drug: Cabotegravir 30 mg micronized new formulation 500 M, Drug: Cabotegravir 30 mg unmicronized new formulation 500 USubjects will receive reference cabotegravir 30 mg current formulation (Treatment A), Cabotegravir 30 mg micronized new formulation 500 M (Treatment B) and Cabotegravir 30 mg unmicronized new formulation 500 U (Treatment C) in one of six sequences ABC, ACB, BCA, BAC, CAB, CBA in three treatment periods under fasting condition |
| Part B | Experimental | Drug: Cabotegravir 30 mg current formulation, Drug: Cabotegravir 30 mg micronized new formulation 650 M, Drug: Cabotegravir 30 mg unmicronized new formulation 650 USubjects will receive reference Cabotegravir 30 mg current formulation (Treatment A), Cabotegravir 30 mg micronized new formulation 650 M (Treatment D) and Cabotegravir 30 mg unmicronized new formulation 650 U (Treatment E) in one of six sequences ADE, AED, DAE, DEA, EAD, EDA in three treatment periods under fasting condition |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Body weight >=50 kilogram (kg) and body mass index (BMI) within the range 18.5 -31.0 kg/ meter square (m^2) (inclusive).
- Male or Female
- Female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test), not lactating, and at least one of the following conditions applies: a) Non-reproductive potential defined as: Pre-menopausal females with one of the following [for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records]: Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy. b) Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause >40 milli-International Units (MIU)/ milliliter (mL) and estradiol <40 picogram (pg)/mL (<147 picomole [pmol]/ liter [L]) is confirmatory]. c) Reproductive potential and agrees to follow one of the options listed below in the GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until after the last dose of study medication and completion of the follow-up visit. GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in FRP are as follows. This list does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis. a) Intrauterine device or intrauterine system that meets the standard operating procedure (SOP) effectiveness criteria including a <1% rate of failure per year, as stated in the product label. b) Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. c) Male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository) only for the following 3 situations when there is a very low risk for developmental toxicity: Vaccines; Monoclonal antibodies when there is no target biology concern; Compounds that have a complete reproductive toxicology package and have not shown any signal for developmental toxicity. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. Sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Key exclusion criteria (12 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 clinically significant cardiovascular disease including: a) Exclusion criteria for screening Electrocardiogram (ECG) (a single repeat is allowed for eligibility determination) Heart rate: Males: <45 and >100 beats per minute, Females: <50 and >100 beats per minute; QRS duration: >120 millisecond (msec), QTc interval (B): >450 msec; b) Evidence of previous myocardial infarction (pathologic Q waves, S-T segment changes (except early repolarization). c) History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PCTA) or any clinically significant cardiac disease. d) Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular block (AV) block [2nd degree (type II) or higher], Wolf Parkinson White [WPW] syndrome). e) Sinus pauses >3 seconds. f) Any significant arrhythmia which, in the opinion of the principal Investigator and GSK Medical Monitor, will interfere with the safety for the individual subject. g) Non-sustained (>=3 consecutive ventricular ectopic beats) or sustained ventricular tachycardia. NOTES: The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read. The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial. For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used as specified in the Reporting and Analysis Plan (RAP).
- Concomitant medications that are prohibited for this study.
- History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams (g) of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- 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 Medical Monitor, contraindicates their participation.
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 |
|---|---|---|
| Cabotegravir 30 mg current formulationCabotegravir 30 mg current formulation (Treatment A) is a film coated tablet with a weight of 824 mg | Drug | Part A, Part B |
| Cabotegravir 30 mg micronized new formulation 500 MCabotegravir 30 mg micronized new formulation 500 M (Treatment B) is a film coated tablet with a weight of 515 mg | Drug | Part A |
| Cabotegravir 30 mg unmicronized new formulation 500 UCabotegravir 30 mg unmicronized new formulation 500 U (Treatment C) is a film coated tablet with a weight of 515 mg | Drug | Part A |
| Cabotegravir 30 mg micronized new formulation 650 MCabotegravir 30 mg micronized new formulation 650 M (Treatment D) is a film coated tablet with a weight of 670 mg | Drug | Part B |
| Cabotegravir 30 mg unmicronized new formulation 650 UCabotegravir 30 mg unmicronized new formulation 650 U (Treatment E) is a film coated tablet with a weight of 670 mg | Drug | Part B |
Primary outcome
Composite of pharmacokinetic (PK) parameters for cabotegravir evaluated by measurement of plasma AUC (0-infinity), AUC (0-t) and Cmax and C24
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post dose.
To evaluate the relative bioavailability of cabotegravir after single 30 mg dose in the fasted state, the following PK parameters will be assessed: area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)), area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments (AUC (0-t)), maximum observed concentration (Cmax) and concentration at 24 hours post-dose (C24)
6 secondary outcomes
Composite of PK parameters for cabotegravir evaluated by measurement of plasma t1/2, tlag, tmax, %AUCex, AUC (0-72), and CL/F
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post dose.
Number of participants with adverse events as a measure of safety and tolerability of Cabotegravir
Time frame: Up to 8 weeks
Safety and tolerability of single oral dose of Cabotegravir assessed by concurrent medication used any time during the study period along with the study medication.
Time frame: Up to 8 weeks
Safety and tolerability of single oral dose of Cabotegravir assessed by clinical laboratory screens
Time frame: Up to 8 weeks
Safety and tolerability of single oral dose of Cabotegravir assessed by12-lead electrocardiogram
Time frame: Up to 8 weeks
Safety and tolerability of single oral dose of Cabotegravir assessed by vital signs
Time frame: Up to 8 weeks
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 Jul 2015.
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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
ViiV Healthcare
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 Cabotegravir 30 mg current formulation, Cabotegravir 30 mg micronized new formulation 500 M and Cabotegravir 30 mg unmicronized new formulation 500 U in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United States.
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 12 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 Jul 2015. 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 United States. 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 for cabotegravir evaluated by measurement of plasma AUC (0-infinity), AUC (0-t) and Cmax and C24 (time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 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 Jul 2015.