Pulmonary Arterial HypertensionPhase 1NCT02746237
Single and Multiple Ascending Doses Clinical Pharmacology Study With KAR5585
A Phase 1 study testing KAR5585 Capsules in people with Pulmonary Arterial Hypertension, run by Karos Pharmaceuticals at 1 site in United States.
Trial summary
Safety, tolerability, pharmacokinetics (PK), cardiac conduction and food effect study on single and multiple ascending doses of KAR5585 in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- KAR5585 Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Aug 2016
- 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
- Subject is able to read, write, and comprehend English at a sufficient level to understand study-related materials
- Subject is able to provide written informed consent and to comply with all study requirements and restrictions
- Subject is male or female and aged 18 to 65 years, inclusive, at the time of informed consent
- Subject is in good health as determined by the PI based on detailed medical history, physical examination, vital signs, clinical laboratory tests, ECGs, and other pre-dose evaluations
- Subject agrees to use a medically acceptable form of birth control from CRU admission until at least 30 days (female subject) or 90 days (male subject) after the last dose of study drug. Males will also not donate sperm from CRU admission until at least 90 days after the last dose of study drug. If a subject is not sexually active but becomes active during study participation, the subject agrees they and their partner will use a medically accepted form of contraception for the time specified. Medically acceptable forms of contraception are:
- FDA-approved female hormonal contraceptives used consistently for 2 or more cycles before Screening, including oral contraceptives, intrauterine device (IUD), medroxyprogesterone acetate injection (Depo Provera®), hormonal implant (Norplant®, Implanon®, Nexplanon®), and vaginal ring (NuvaRing®)
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- Male condom plus spermicide
- Male condom plus contraceptive sponge, foam, or jelly
- Female condom plus spermicide
- Diaphragm with spermicide plus male condom
- Cervical cap with spermicide plus male condom
- Surgical sterilization of the subject or partner (vasectomy for males, hysterectomy or bilateral oophorectomy for females)
- Abstinence
- If female, subject agrees that a serum pregnancy test ([β hCG] beta human chorionic gonadotropin ) will be performed at Screening, on Day 2 (CRU admission), and at the last study visit and negative test results at Screening and CRU admission are required to be considered for study participation
- Subject has a body mass index (BMI) of 20 to 35 kg/m2, inclusive, and body weight < 120 kg at Screening
Who cannot join
- Subject currently uses tobacco or nicotine-containing products or has used such products within 6 months before CRU admission
- Subject has history or current evidence of any clinically significant cardiac, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the PI
- Subject has a history of cancer within 5 years before CRU admission (excluding non-melanoma skin cancer)
- Subject has a history of autonomic dysfunction (eg, history of repeated dizziness, fainting, or symptomatic orthostatic hypotension)
- Subject has a history of risk factors for torsades de pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, OR clinically significant abnormal laboratory assessments including hypokalemia, hypomagnesemia, or hypercalcemia OR has a family history of long QT syndrome or Brugada syndrome
- Subject has 1 or more clinically significant abnormal laboratory test values (as determined by the PI)
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- Subject has an uninterpretable or abnormal screening ECG indicating a second- or third-degree atrioventricular block, or 1 or more of the following: QRS interval (ventricular depolarization) > 110 msec; a PR interval (atrioventricular conduction) > 220 msec, or QTc (corrected QT interval) of ≥ 450 msec (for male) or ≥ 470 msec (for female) or any rhythm other than sinus rhythm that is interpreted by the PI or a qualified designee to be clinically significant
- Subject has a resting heart rate (HR) of < 40 beats/min or > 90 beats/min at Screening or on CRU admission
- Subject has a sustained supine systolic blood pressure (BP) > 155 or < 90 mm Hg or a supine diastolic BP > 95 or < 50 mm Hg at Screening or upon CRU admission. Blood pressure in the supine position may be retested once and 'sustained' is defined as the parameter (either systolic or diastolic BP) being outside the stated limits at both assessments.
- Subject participates in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, before CRU admission
- Subject has a history of alcohol or drug abuse or dependence within 12 months before CRU admission, as determined by the PI
- Subject has a clinically significant infection within 3 months before CRU admission, as determined by the PI
- Subject has any condition that, in the opinion of the PI, would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study
- Subject has a positive urine screen for prohibited drugs (cocaine, cannabinoids, nicotine [urine cotinine is the detection mechanism for nicotine], opiates, barbiturates, amphetamines, and benzodiazepines) or positive urine test for alcohol
- Subject has a positive blood screen for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus antibody at the Screening Visit
- Subject has had a known or suspected hypersensitivity or idiosyncratic reaction to the cellulose used in the placebo to be used in this study
- Subject has donated blood or any blood products within 3 months before Screening or plans to donate blood during or within 3 months after study completion
- Subject consumes an excessive amount of caffeine daily, defined as > 4 cups of coffee or equivalent per day. Subjects will abstain from caffeine consumption for 48 hours before dosing and while confined to the CRU.
- Subject has consumed or will consume any concomitant therapy; prescription or over-the-counter (OTC) medication; or nutritional, herbal, or vitamin supplements other than contraceptives (eg, oral, systemic) and ibuprofen (only if needed, maximum 2.4 g/day) from 14 days or 5 half-lives (whichever is longer) before dosing and while confined to the CRU
- For Part 2 only: Subject has consumed any food, juice, beverage, or medication (prescription or non-prescription) containing acetaminophen, alcohol, avocado, banana, caffeine, eggplant, kiwi fruit, nut (hickory nut, pecan, walnut), pineapple, plum, or tomato products within 48 hours before CRU admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 1, First-in-human, Single-center, Safety, Tolerability, Ventricular Repolarization and Pharmacokinetic Study of Single and Multiple Ascending Doses of KAR5585 in Healthy Subjects
Safety, tolerability, pharmacokinetics (PK), cardiac conduction and food effect study on single and multiple ascending doses of KAR5585 in healthy adults.
Read the detailed description
The purpose of this study is to explore the safety, tolerability, pharmacokinetics (PK), and cardiac conduction effects of single and multiple ascending doses of KAR5585 in healthy adults. Food effect will also be evaluated after a single-dose administration.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- KAR5585 Capsules, Placebo Capsules
- Keywords
- Serotonin, Pulmonary Arterial Hypertension, Pharmacokinetics, Phase 1, Healthy Volunteers
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAR5585 CapsulesDrug
Also called KAR5585
Single and multiple ascending doses of KAR5585 (100 mg initial dose)
Placebo CapsulesDrug
Single and multiple ascending doses of placebo (100 mg initial dose)
| Study group | Role | What they receive |
|---|---|---|
| KAR5585 | Experimental | KAR5585 Capsules Receives: Drug: KAR5585 Capsules |
| Placebo | Placebo comparator | Placebo capsules Receives: Drug: Placebo Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with abnormal physical exam results
Healthy adult volunteers receiving single and multiple doses of KAR5585 administered orally will be monitored for adverse events via physical examination.
Measured: From baseline to 4 days post-dose for single dose and baseline to 6 days post-dose for multiple doses
Number of participants with abnormal hematology values
Healthy adult volunteers receiving single and multiple doses of KAR5585 administered orally will be monitored for adverse events via lab evaluation of hematology.
Measured: From baseline to 4 days post-dose for single dose and baseline to 6 days post-dose for multiple doses
Number of participants with abnormal electrocardiogram results
Healthy adult volunteers receiving single and multiple doses of KAR5585 administered orally will be monitored for abnormal ECG results.
Measured: From baseline to 4 days post-dose for single dose and baseline to 6 days post-dose for multiple doses
Number of participants with abnormal clinical chemistry values
Healthy adult volunteers receiving single and multiple doses of KAR5585 administered orally will be monitored for adverse events via lab evaluation of clinical chemistries.
Measured: From baseline to 4 days post-dose for single dose and baseline to 6 days post-dose for multiple doses
Number of participants with abnormal urinalysis values
Healthy adult volunteers receiving single and multiple doses of KAR5585 administered orally will be monitored for adverse events via lab evaluation of urinalysis.
Measured: From baseline to 4 days post-dose for single dose and baseline to 6 days post-dose for multiple doses
Secondary outcomes (15)
Plasma area under the curve (AUC0-24) of prodrug KAR5585 and active inhibitor KAR5417 from time zero to 24 hours after dosing
Assessment of AUC 0-24 hours measured on Day 1, 7 and 14 when drug is dosed without a meal
Measured: From 0-24 hours on Days 1, 7 and 14
Time to reach maximum observed plasma concentration (Tmax) of prodrug KAR5585 and active inhibitor KAR5417
Assessment of Tmax measured on Day 1, 7 and 14 when drug is dosed without a meal
Measured: From 0-24 hours on Days 1, 7 and 14
Plasma terminal elimination half- life (T1/2) of prodrug KAR5585 and active inhibitor KAR5417
Assessment of T1/2 measured on Day 1, 7 and 14 when drug is dosed without a meal
Measured: From 0-24 hours on Days 1, 7 and 14
Apparent volume of distribution (Vz/F) of prodrug KAR5585 and active inhibitor KAR5417
Assessment of Vz/F measured on Day 1, 7 and 14 when drug is dosed without a meal
Measured: From 0-24 hours on Days 1, 7 and 14
Maximum peak concentration (Cmax) of prodrug KAR5585 and active inhibitor KAR5417
Assessment of Cmax measured on Day 1, 7 and 14 when drug is dosed without a meal
Measured: From 0-24 hours on Days 1, 7 and 14
Serum levels of serotonin (ng/mL)
Serum serotonin (5-HT) levels will be measured to evaluate the pharmacodynamic effects of KAR5585 administration
Measured: Days 1, 7 and 14
Urinary levels of 5-hydroxyindoleacetic acid(mg/24 hrs)
24 hour urine collection with analysis for 5-HIAA (5-hydroxyindoleacetic acid) levels.
Measured: From 0-24 hours on Days 1, 7 and 14
Urinary levels of creatinine (gm/24 hrs)
24 hour urine collection with analysis for creatinine levels.
Measured: From 0-24 hours on Days 1, 7 and 14
Urinary levels of 5-hydroxyindoleacetic acid normalized to creatinine (mg/gm)
24 hour urine collection with analysis for 5-HIAA (5-hydroxyindoleacetic acid). Urinary creatinine will be used to normalize urinary 5-HIAA levels: urinary 5-HIAA mg/gm creatinine
Measured: From 0-24 hours on Days 1, 7 and 14
Plasma levels of 5-hydroxyindoleacetic acid (ng/mL)
Plasma 5-HIAA (5-hydroxyindoleacetic acid) levels will be measured to evaluate the pharmacodynamic effects of KAR5585 administration
Measured: Days 1, 7 and 14
Plasma area under the curve (AUC0-24) of prodrug KAR5585 and active inhibitor KAR5417 from time zero to 24 hours after dosing
To determine the effect of food intake on the pharmacokinetics of KAR5585 and its active metabolite KAR5417, a cohort of patients will be studied after a single dose given fasting, followed by the same dose given with a high fat content food.
Measured: From 0-24hrs on Days 1, 7 and 14
Time to reach maximum observed plasma concentration (Tmax) of prodrug KAR5585 and active inhibitor KAR5417
To determine the effect of food intake on the pharmacokinetics of KAR5585 and its active metabolite KAR5417, a cohort of patients will be studied after a single dose given fasting, followed by the same dose given with a high fat content food.
Measured: From 0-24hrs on Days 1, 7 and 14
Plasma terminal elimination half-life (T1/2) of prodrug KAR5585 and active inhibitor KAR5417
To determine the effect of food intake on the pharmacokinetics of KAR5585 and its active metabolite KAR5417, a cohort of patients will be studied after a single dose given fasting, followed by the same dose given with a high fat content food.
Measured: From 0-24hrs on Days 1, 7 and 14
Apparent volume of distribution (Vz/F) of prodrug KAR5585 and active inhibitor KAR5417
To determine the effect of food intake on the pharmacokinetics of KAR5585 and its active metabolite KAR5417, a cohort of patients will be studied after a single dose given fasting, followed by the same dose given with a high fat content food.
Measured: From 0-24hrs on Days 1, 7 and 14
Maximum peak concentration (Cmax) of prodrug KAR5585 and active inhibitor KAR5417
To determine the effect of food intake on the pharmacokinetics of KAR5585 and its active metabolite KAR5417, a cohort of patients will be studied after a single dose given fasting, followed by the same dose given with a high fat content food.
Measured: From 0-24hrs on Days 1, 7 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karos Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Sanabria, MD, Principal investigator, Spaulding Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746237
- Sponsor's protocol ID
- KAR5585-101
- Status last verified
- Aug 2016
- First submitted
- 18 Mar 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase 1, First-in-human, Single-center, Safety, Tolerability, Ventricular Repolarization and Pharmacokinetic Study of Single and Multiple Ascending Doses of KAR5585 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02746237
- Acronym / sponsor ID
- KAR5585-101
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Serotonin, Pulmonary Arterial Hypertension, Pharmacokinetics, Phase 1, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karos PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 Apr 2016 (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.
Safety, tolerability, pharmacokinetics (PK), cardiac conduction and food effect study on single and multiple ascending doses of KAR5585 in healthy adults.
Detailed description
The purpose of this study is to explore the safety, tolerability, pharmacokinetics (PK), and cardiac conduction effects of single and multiple ascending doses of KAR5585 in healthy adults. Food effect will also be evaluated after a single-dose administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KAR5585 | Experimental | Drug: KAR5585 CapsulesKAR5585 Capsules |
| Placebo | Placebo comparator | Drug: Placebo CapsulesPlacebo capsules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subject is able to read, write, and comprehend English at a sufficient level to understand study-related materials
- Subject is able to provide written informed consent and to comply with all study requirements and restrictions
- Subject is male or female and aged 18 to 65 years, inclusive, at the time of informed consent
- Subject is in good health as determined by the PI based on detailed medical history, physical examination, vital signs, clinical laboratory tests, ECGs, and other pre-dose evaluations
- Subject agrees to use a medically acceptable form of birth control from CRU admission until at least 30 days (female subject) or 90 days (male subject) after the last dose of study drug. Males will also not donate sperm from CRU admission until at least 90 days after the last dose of study drug. If a subject is not sexually active but becomes active during study participation, the subject agrees they and their partner will use a medically accepted form of contraception for the time specified. Medically acceptable forms of contraception are:
Key exclusion criteria (20 listed)
- Subject currently uses tobacco or nicotine-containing products or has used such products within 6 months before CRU admission
- Subject has history or current evidence of any clinically significant cardiac, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the PI
- Subject has a history of cancer within 5 years before CRU admission (excluding non-melanoma skin cancer)
- Subject has a history of autonomic dysfunction (eg, history of repeated dizziness, fainting, or symptomatic orthostatic hypotension)
- Subject has a history of risk factors for torsades de pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, OR clinically significant abnormal laboratory assessments including hypokalemia, hypomagnesemia, or hypercalcemia OR has a family history of long QT syndrome or Brugada syndrome
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 |
|---|---|---|
| KAR5585 CapsulesAlso: KAR5585Single and multiple ascending doses of KAR5585 (100 mg initial dose) | Drug | KAR5585 |
| Placebo CapsulesSingle and multiple ascending doses of placebo (100 mg initial dose) | Drug | Placebo |
Primary outcome
Number of participants with abnormal physical exam results
Time frame: From baseline to 4 days post-dose for single dose and baseline to 6 days post-dose for multiple doses
Healthy adult volunteers receiving single and multiple doses of KAR5585 administered orally will be monitored for adverse events via physical examination.
Number of participants with abnormal hematology values
Time frame: From baseline to 4 days post-dose for single dose and baseline to 6 days post-dose for multiple doses
Healthy adult volunteers receiving single and multiple doses of KAR5585 administered orally will be monitored for adverse events via lab evaluation of hematology.
Number of participants with abnormal electrocardiogram results
Time frame: From baseline to 4 days post-dose for single dose and baseline to 6 days post-dose for multiple doses
Healthy adult volunteers receiving single and multiple doses of KAR5585 administered orally will be monitored for abnormal ECG results.
Number of participants with abnormal clinical chemistry values
Time frame: From baseline to 4 days post-dose for single dose and baseline to 6 days post-dose for multiple doses
Healthy adult volunteers receiving single and multiple doses of KAR5585 administered orally will be monitored for adverse events via lab evaluation of clinical chemistries.
Number of participants with abnormal urinalysis values
Time frame: From baseline to 4 days post-dose for single dose and baseline to 6 days post-dose for multiple doses
Healthy adult volunteers receiving single and multiple doses of KAR5585 administered orally will be monitored for adverse events via lab evaluation of urinalysis.
15 secondary outcomes
Plasma area under the curve (AUC0-24) of prodrug KAR5585 and active inhibitor KAR5417 from time zero to 24 hours after dosing
Time frame: From 0-24 hours on Days 1, 7 and 14
Time to reach maximum observed plasma concentration (Tmax) of prodrug KAR5585 and active inhibitor KAR5417
Time frame: From 0-24 hours on Days 1, 7 and 14
Plasma terminal elimination half- life (T1/2) of prodrug KAR5585 and active inhibitor KAR5417
Time frame: From 0-24 hours on Days 1, 7 and 14
Apparent volume of distribution (Vz/F) of prodrug KAR5585 and active inhibitor KAR5417
Time frame: From 0-24 hours on Days 1, 7 and 14
Maximum peak concentration (Cmax) of prodrug KAR5585 and active inhibitor KAR5417
Time frame: From 0-24 hours on Days 1, 7 and 14
Serum levels of serotonin (ng/mL)
Time frame: Days 1, 7 and 14
Urinary levels of 5-hydroxyindoleacetic acid(mg/24 hrs)
Time frame: From 0-24 hours on Days 1, 7 and 14
Urinary levels of creatinine (gm/24 hrs)
Time frame: From 0-24 hours on Days 1, 7 and 14
Urinary levels of 5-hydroxyindoleacetic acid normalized to creatinine (mg/gm)
Time frame: From 0-24 hours on Days 1, 7 and 14
Plasma levels of 5-hydroxyindoleacetic acid (ng/mL)
Time frame: Days 1, 7 and 14
Plasma area under the curve (AUC0-24) of prodrug KAR5585 and active inhibitor KAR5417 from time zero to 24 hours after dosing
Time frame: From 0-24hrs on Days 1, 7 and 14
Time to reach maximum observed plasma concentration (Tmax) of prodrug KAR5585 and active inhibitor KAR5417
Time frame: From 0-24hrs on Days 1, 7 and 14
Plasma terminal elimination half-life (T1/2) of prodrug KAR5585 and active inhibitor KAR5417
Time frame: From 0-24hrs on Days 1, 7 and 14
Apparent volume of distribution (Vz/F) of prodrug KAR5585 and active inhibitor KAR5417
Time frame: From 0-24hrs on Days 1, 7 and 14
Maximum peak concentration (Cmax) of prodrug KAR5585 and active inhibitor KAR5417
Time frame: From 0-24hrs on Days 1, 7 and 14
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 30 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Carlos Sanabria, MD principal investigator
Spaulding Clinical
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 KAR5585 Capsules in people with Pulmonary Arterial Hypertension, run by Karos Pharmaceuticals 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 15 inclusion and 20 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 30 Aug 2016. 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. 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?
Number of participants with abnormal physical exam results (time frame: From baseline to 4 days post-dose for single dose and baseline to 6 days post-dose for multiple doses). The study lists 5 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 30 Aug 2016.