Systemic Lupus ErythematosusPhase 1JAK116439NCT01687309
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK2586184 and the Effect of Food and Gender
A Phase 1 study testing GSK2586184 800mg single and repeat dose, GSK2586184 single dose taken with food and GSK2586184 single dose taken without food in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 1 site in Belgium.
Trial summary
A study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and repeat doses of 800 mg GSK2586184 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- GSK2586184 800mg single and repeat dose, GSK2586184 single dose taken with food and GSK2586184 single dose taken without food
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Apr 2012to 31 Jul 2012
- 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
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring
- Cohort A: A female subject of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
- Cohort B: Male subjects with female partners of child-bearing potential must agree to contraception method mandated by protocol
- Cohort A: Subjects between 18 and 65 years of age inclusive, at the time of signing the informed consent
- Cohort B: Subjects between 18 and 50 years of age inclusive, at the time of signing the informed consent
- Normal creatinine clearance values at screening
Show all 10Show fewer
- ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- Single QTcF < 480 msec
- BMI within the range 18 - 30.0 kg/m2 (inclusive)
- Subjects must be non-smokers and must not use any nicotine-containing products. A non-smoker is defined as an individual who has abstained from smoking for at least 1 year prior to screening
Who cannot join
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- A positive pre-study drug/alcohol screen
- A positive test for HIV antibody
- History of sensitivity to any of the study medications, Intron A or other recombinant interferons, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation
- History of 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 g of alcohol and the following can be used as a guide: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits
Show all 14Show fewer
- 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)
- The subject is unwilling to abstain from alcohol consumption from 48 hr prior to dosing until discharge from the clinic, and for 24 hr prior to all other out-patient clinic visits
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day
- Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety
- History of malignancy, except for adequately treated non-invasive cancer of the skin (basal or squamous cell) or cervical carcinoma in situ (>2 yrs 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
- Subjects with a history of or a current thyroid disease or epilepsy
- Subjects exposed to radiation in the 6 months, (except for X-ray/CT examinations of the extremities) prior to the first GFR assessment (Day -2) (cohort B only)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2586184 Following a Single Doseof 800mg and Repeat Oral Tablet Doses of 800mg b.d and the Effect of Food and Gender on the Pharmacokinetics of oralGSK2586184 in Healthy Subjects
A study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and repeat doses of 800 mg GSK2586184 in healthy subjects.
Read the detailed description
This is a study in healthy volunteers to investigate the safety, tolerability, pharmacokinetics (the body's effect on the drug) and pharmacodynamics (the drug's effect on the body) of single and repeat doses of 800 mg GSK2586184. The effect of food and gender on pharmacokinetics will also be investigated following single dosing.
The study is made up of 2 groups of healthy subjects. The first group consists of 6 female subjects who will receive a single dose of 800mg GSK2586184 (study medication) during 2 seperate sessions. One session will involve the female subjects taking the study medication with food and the other session will involve study medication being taken without food. The safety and tolerability of the study medication in female subjects and the effect of food on the pharmacokinetics of the study medication will be investigated.
The second group will consist of 12 healthy male subjects participating in 2 sessions. 8 subjects will receive study medication and 4 will receive placebo (dummy medication) during the course of the study. Neither they or their study doctor will know which one they are given. Each male subject will receive a single dose of study medication or placebo followed by 13 days of twice daily dosing of study medication or placebo. Each dose will be taken with food.The single dose results from this group of subjects will be compared to the female group to investigate the effect of gender on pharmacokinetics. The safety and pharmacokinetics of repeat dosing will be investigated. The effect of repeat dosing on kidney function and the immune system will also be investigated.
The study will take place in the SGS Clinical Pharmacology Unit in Antwerp, Belgium. A pharmaceutical company, GlaxoSmithKline, is funding the study.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- GSK2586184 800mg single and repeat dose, Placebo-to-match GSK2586184, GSK2586184 single dose taken with food, GSK2586184 single dose taken without food
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2586184 800mg single and repeat doseDrug
GSK2586184 800mg single dose and then twice daily dosing for 13 days
Placebo-to-match GSK2586184Drug
Placebo-to-match GSK2586184
GSK2586184 single dose taken with foodOther
GSK2586184 single dose taken with FDA approved high fat, high calorie breakfast
GSK2586184 single dose taken without foodOther
GSK2586184 single dose taken in a fasted state
| Study group | Role | What they receive |
|---|---|---|
| Cohort A fed session | Other | GSK2586184 800mg single dose with food Receives: Other: GSK2586184 single dose taken with food |
| Cohort A fasted session | Other | GSK2586184 single dose without food Receives: Other: GSK2586184 single dose taken without food |
| Cohort B active study medication | Active comparator | GSK2586184 800mg single and twice daily dose for 13 days Receives: Drug: GSK2586184 800mg single and repeat dose |
| Cohort B placebo | Placebo comparator | Placebo-to-match single and twice daily dose for 13 days Receives: Drug: Placebo-to-match GSK2586184 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event reporting
Change in health of subjects
Measured: Day 1 through to within 7-10 days after the last dose
Change from baseline in clinical chemistry, hematology, urinalysis
Change in clinical chemistry, hematology and urinalysis from baseline
Measured: Cohort A: D-1, predose (each session), D2 (each session) and 7-10 days after the last dose. Cohort B single dose session: D-3, predose, D2. Cohort B repeat dose session: D1, D2, D5, D10, D11, D14 and within 7-10 days after last dose
Change from baseline in vital signs parameters
Change in blood pressure, heart rate and body temperature outside normal range
Measured: Cohort A: Predose, 2h post dose, D2, within 7-10 days from last dose. Cohort B single dose session: D-3, predose, 2h post-dose, D2. Cohort B repeat dose session: predose on D1, D2, D5, D10, 2h post-dose on D1 and D10, D14, within 7-10 days post last dose
Change from baseline in ECG parameters
Change in ECG parameters outside normal range
Measured: Cohort A: Predose, 2h post dose, D2 and within 7-10 days of last dose. Cohort B single dose session: D-3, pre-dose, 2h post-dose and D2. Cohort B repeat dose session: pre-dose, D2, D5, D10, 2h post-dose on D1, D10, D14 and within 7-10 days from last dose
Plasma concentrations of GSK2586184
Change in plasma concentrations of GSK2586184
Measured: Cohort A: 0.25, 0.5, 1, 2, 4, 8, 12, 24 and 48h post-dose. Cohort B single dose session:0.25, 0.5, 1, 2, 4, 8, 12, 24 and 48h post-dose. Cohort B repeat dose session: D1 and D10 (predose, 0.25, 0.5, 1, 2, 4, 8 and 12h post-dose), D2, D3, D4, D5, and D11
Change from baseline for 24h urine albumin, creatinine and PCR
Change in 24h urine creatinine, albumin and PCR values outside normal range
Measured: Cohort B repeat dose: D-1, D10 and within 7-10 days post last dose
Secondary outcomes (6)
mRNA expression of IFNa and JAK pathway genes
Change in mRNA expression profile of IFNa and JAK pathway genes
Measured: Cohort B repeat dose: Predose, 1, 2, 4, 8 and 12h on D1 and D10. Predose, 1, 2, 4, 8, 12 and 24h post-dose on D11
Vital signs as a pharmacodynamic endpoint
Change in blood pressure, heart rate and body temperature post IFNa challenge
Measured: Cohort B repeat dose: Predose, 4, 8, 12, 24, 28, 32, 48, 72, 100 and 120h post dose on D11
Plasma levels of Neopterin and B2-microglobulin
Change in plasma concentrations of neopterin and B2-microglobulin post IFNa challenge
Measured: Cohort B repeat dose: Predose, 4, 8, 12, 24, 28, 32, 48, 72, 100 and 120h post dose on D11
Glomerular Filtration Measurement using Cr-51 EDTA
Change in plasma concentrations of Cr-51 EDTA and it's derived clearance
Measured: Cohort B: 2h and 4h post Cr-51 EDTA injection on D-2 of single dose session, D8 of repeat dose session and within 7-10 days post last dose
Duodenal concentrations of GSK2586184 and its metabolites and derived pharmacokinetic parameters
Change in bile concentrations of GSK2586184 and it's metabolites
Measured: Cohort A: D-1 to D1 predose and 2.5h post-dose to 6.5h post-dose. Cohort B single dose: D-1 to D1 predose and 2.5h post-dose to 6.5h post-dose
Urine concentrations of GSK2586184 and its metabolites and derived pharmacokinetic parameters
Change in urine concentration of GSK2586184 and it's metabolites
Measured: Cohort A: D1 predose and for 24 hr post-dose.Cohort B single dose: D1 predose and for 24h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study start30 Apr 2012
- Primary completion31 Jul 2012
- Study completion31 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 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
- NCT01687309
- Sponsor's protocol ID
- 116439
- Acronym
- JAK116439
- Status last verified
- May 2018
- First submitted
- 10 May 2012
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2586184 Following a Single Doseof 800mg and Repeat Oral Tablet Doses of 800mg b.d and the Effect of Food and Gender on the Pharmacokinetics of oralGSK2586184 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01687309
- Acronym / sponsor ID
- JAK116439 / 116439
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2012 (actual)
- Primary completion
- 31 Jul 2012 (actual)
- Study completion
- 31 Jul 2012 (actual)
- First posted
- 18 Sep 2012 (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.
A study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and repeat doses of 800 mg GSK2586184 in healthy subjects.
Detailed description
This is a study in healthy volunteers to investigate the safety, tolerability, pharmacokinetics (the body's effect on the drug) and pharmacodynamics (the drug's effect on the body) of single and repeat doses of 800 mg GSK2586184. The effect of food and gender on pharmacokinetics will also be investigated following single dosing.
The study is made up of 2 groups of healthy subjects. The first group consists of 6 female subjects who will receive a single dose of 800mg GSK2586184 (study medication) during 2 seperate sessions. One session will involve the female subjects taking the study medication with food and the other session will involve study medication being taken without food. The safety and tolerability of the study medication in female subjects and the effect of food on the pharmacokinetics of the study medication will be investigated.
The second group will consist of 12 healthy male subjects participating in 2 sessions. 8 subjects will receive study medication and 4 will receive placebo (dummy medication) during the course of the study. Neither they or their study doctor will know which one they are given. Each male subject will receive a single dose of study medication or placebo followed by 13 days of twice daily dosing of study medication or placebo. Each dose will be taken with food.The single dose results from this group of subjects will be compared to the female group to investigate the effect of gender on pharmacokinetics. The safety and pharmacokinetics of repeat dosing will be investigated. The effect of repeat dosing on kidney function and the immune system will also be investigated.
The study will take place in the SGS Clinical Pharmacology Unit in Antwerp, Belgium. A pharmaceutical company, GlaxoSmithKline, is funding the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A fed session | Other | Other: GSK2586184 single dose taken with foodGSK2586184 800mg single dose with food |
| Cohort A fasted session | Other | Other: GSK2586184 single dose taken without foodGSK2586184 single dose without food |
| Cohort B active study medication | Active comparator | Drug: GSK2586184 800mg single and repeat doseGSK2586184 800mg single and twice daily dose for 13 days |
| Cohort B placebo | Placebo comparator | Drug: Placebo-to-match GSK2586184Placebo-to-match single and twice daily dose for 13 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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
- Cohort A: A female subject of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
- Cohort B: Male subjects with female partners of child-bearing potential must agree to contraception method mandated by protocol
- Cohort A: Subjects between 18 and 65 years of age inclusive, at the time of signing the informed consent
- Cohort B: Subjects between 18 and 50 years of age inclusive, at the time of signing the informed consent
Key exclusion criteria (14 listed)
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- A positive pre-study drug/alcohol screen
- A positive test for HIV antibody
- History of sensitivity to any of the study medications, Intron A or other recombinant interferons, 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
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 |
|---|---|---|
| GSK2586184 800mg single and repeat doseGSK2586184 800mg single dose and then twice daily dosing for 13 days | Drug | Cohort B active study medication |
| Placebo-to-match GSK2586184Placebo-to-match GSK2586184 | Drug | Cohort B placebo |
| GSK2586184 single dose taken with foodGSK2586184 single dose taken with FDA approved high fat, high calorie breakfast | Other | Cohort A fed session |
| GSK2586184 single dose taken without foodGSK2586184 single dose taken in a fasted state | Other | Cohort A fasted session |
Primary outcome
Adverse event reporting
Time frame: Day 1 through to within 7-10 days after the last dose
Change in health of subjects
Change from baseline in clinical chemistry, hematology, urinalysis
Time frame: Cohort A: D-1, predose (each session), D2 (each session) and 7-10 days after the last dose. Cohort B single dose session: D-3, predose, D2. Cohort B repeat dose session: D1, D2, D5, D10, D11, D14 and within 7-10 days after last dose
Change in clinical chemistry, hematology and urinalysis from baseline
Change from baseline in vital signs parameters
Time frame: Cohort A: Predose, 2h post dose, D2, within 7-10 days from last dose. Cohort B single dose session: D-3, predose, 2h post-dose, D2. Cohort B repeat dose session: predose on D1, D2, D5, D10, 2h post-dose on D1 and D10, D14, within 7-10 days post last dose
Change in blood pressure, heart rate and body temperature outside normal range
Change from baseline in ECG parameters
Time frame: Cohort A: Predose, 2h post dose, D2 and within 7-10 days of last dose. Cohort B single dose session: D-3, pre-dose, 2h post-dose and D2. Cohort B repeat dose session: pre-dose, D2, D5, D10, 2h post-dose on D1, D10, D14 and within 7-10 days from last dose
Change in ECG parameters outside normal range
Plasma concentrations of GSK2586184
Time frame: Cohort A: 0.25, 0.5, 1, 2, 4, 8, 12, 24 and 48h post-dose. Cohort B single dose session:0.25, 0.5, 1, 2, 4, 8, 12, 24 and 48h post-dose. Cohort B repeat dose session: D1 and D10 (predose, 0.25, 0.5, 1, 2, 4, 8 and 12h post-dose), D2, D3, D4, D5, and D11
Change in plasma concentrations of GSK2586184
Change from baseline for 24h urine albumin, creatinine and PCR
Time frame: Cohort B repeat dose: D-1, D10 and within 7-10 days post last dose
Change in 24h urine creatinine, albumin and PCR values outside normal range
6 secondary outcomes
mRNA expression of IFNa and JAK pathway genes
Time frame: Cohort B repeat dose: Predose, 1, 2, 4, 8 and 12h on D1 and D10. Predose, 1, 2, 4, 8, 12 and 24h post-dose on D11
Vital signs as a pharmacodynamic endpoint
Time frame: Cohort B repeat dose: Predose, 4, 8, 12, 24, 28, 32, 48, 72, 100 and 120h post dose on D11
Plasma levels of Neopterin and B2-microglobulin
Time frame: Cohort B repeat dose: Predose, 4, 8, 12, 24, 28, 32, 48, 72, 100 and 120h post dose on D11
Glomerular Filtration Measurement using Cr-51 EDTA
Time frame: Cohort B: 2h and 4h post Cr-51 EDTA injection on D-2 of single dose session, D8 of repeat dose session and within 7-10 days post last dose
Duodenal concentrations of GSK2586184 and its metabolites and derived pharmacokinetic parameters
Time frame: Cohort A: D-1 to D1 predose and 2.5h post-dose to 6.5h post-dose. Cohort B single dose: D-1 to D1 predose and 2.5h post-dose to 6.5h post-dose
Urine concentrations of GSK2586184 and its metabolites and derived pharmacokinetic parameters
Time frame: Cohort A: D1 predose and for 24 hr post-dose.Cohort B single dose: D1 predose and for 24h 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 25 May 2018.
- Results for study 116439 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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 GSK2586184 800mg single and repeat dose, GSK2586184 single dose taken with food and GSK2586184 single dose taken without food in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 1 site in Belgium.
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 10 inclusion and 14 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 25 May 2018. 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 Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event reporting (time frame: Day 1 through to within 7-10 days after the last dose). 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?
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 25 May 2018.