HealthyPhase 1AVN005NCT00910455
Study of SRX246 Capsules in Healthy Adult Volunteers
A Phase 1 study testing SRX246 in people with Healthy, run by Azevan Pharmaceuticals at 1 site in United States.
Trial summary
This is the first study of SRX246 in humans, and is being conducted to begin to establish a safety profile of orally administered SRX246. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SRX246
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Sep 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and non-pregnant, non-lactating females of non-childbearing potential. Female patients should be either post-menopausal or surgically sterile.
- Age ≥18 and ≤55 years.
- Body mass index (BMI) of 18.5 to 34.0 kg/m2, inclusive, and a total body weight of >50kg (110 pounds).
- In good health as determined by medical history, a baseline physical examination, vital signs, clinical laboratory tests and electrocardiogram (ECG) measurement.
- Subject is willing and able to sign written informed consent prior to receipt of any study medication or beginning study procedures.
- Subject is willing and able to follow instructions, comply with the protocol requirements and make all required study visits.
Who cannot join
- Pregnant or lactating females, or females of childbearing potential.
- Subject is positive for HIV, hepatitis B surface antigen or hepatitis C antibody tests at screening.
- Subject with a positive urine test for drugs of abuse or alcohol at screening or at admission to the clinic on study Day -1.
- Evidence of any out-of range laboratory value at screening that has not been reviewed, approved and documented as not clinically significant by the Principal Investigator.
- Subject who has resting supine blood pressure outside of a systolic blood pressure range of 90-140 mmHg or a diastolic blood pressure outside a range of 50-90 mmHg on two consecutive measurements taken up to 10 minutes apart.
- Subject who has resting supine pulse rate greater than 100 bpm or less than 50 bpm on two consecutive measurements taken up to 10 minutes apart.
Show all 16Show fewer
- Subject has taken any alcohol within 48 hours of ANY study-related activities AND cannot abstain from drinking alcohol during the entire duration of the subject's study participation.
- Subject has used any tobacco products in the past 12 months.
- A history of significant drug allergy or systemic allergic disease (e.g., urticaria, atopic dermatitis).
- A general medical or psychological condition or behavior, including current substance dependence or abuse that, in the opinion of the investigator, might not permit the subject to complete the study or sign the informed consent.
- Any clinically significant abnormality on screening 12-lead ECG (e.g., heart block, conduction disorders, ventricular and/or atrial arrhythmias).
- Any other condition or clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening that, in the opinion of the Principal Investigator or the Physician Sub-Investigator, would make the subject unsuitable for the study or put them at additional risk.
- Routine or PRN consumption of medications or herbal supplements that the subject is unable or unwilling to discontinue during the study.
- Inability to understand or follow study instructions.
- Treatment with an investigational drug within 30 days preceding the first dose of study medication.
- Known allergy or hypersensitivity to the investigational study drug/placebo components.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Biomedical Research
Hackensack, New Jersey, 07601
About this study
Official title: Phase I, Double-Blind, Placebo-Controlled, Ascending, Single-Dose, Safety, Tolerability and Pharmacokinetic Study of SRX246 Capsules in Healthy Adult Volunteers
This is the first study of SRX246 in humans, and is being conducted to begin to establish a safety profile of orally administered SRX246.
Read the detailed description
This protocol represents the first in human study of SRX246, and is being conducted to begin to establish a safety profile, and collect human tolerability and pharmacokinetic data of orally administered SRX246.
- Conditions
- Healthy
- Being tested
- SRX246, Placebo
- Keywords
- Phase 1, Safety, Tolerability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRX246Drug
single oral dose of SRX246 capsule
PlaceboDrug
Single oral dose of placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Single oral dose of SRX246 capsule Receives: Drug: SRX246 |
| Placebo | Placebo comparator | Single oral dose of placebo capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess safety and tolerability of SRX246 at single doses ranging between 20 and 360 mg
Measured: 24 hours
Secondary outcomes (1)
To assess Pharmacokinetics of SRX246 at single doses ranging between 20 and 360 mg
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azevan Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Benno G Roesch, MD, Principal investigator, Advanced Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910455
- Sponsor's protocol ID
- AVN005
- Acronym
- AVN005
- Status last verified
- Mar 2010
- First submitted
- 27 May 2009
- Last updated
- 17 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Double-Blind, Placebo-Controlled, Ascending, Single-Dose, Safety, Tolerability and Pharmacokinetic Study of SRX246 Capsules in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT00910455
- Acronym / sponsor ID
- AVN005 / AVN005
- Conditions
- Healthy
- Keywords
- Phase 1, Safety, Tolerability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Azevan PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 29 May 2009 (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 is the first study of SRX246 in humans, and is being conducted to begin to establish a safety profile of orally administered SRX246.
Detailed description
This protocol represents the first in human study of SRX246, and is being conducted to begin to establish a safety profile, and collect human tolerability and pharmacokinetic data of orally administered SRX246.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: SRX246Single oral dose of SRX246 capsule |
| Placebo | Placebo comparator | Drug: PlaceboSingle oral dose of placebo capsule |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males and non-pregnant, non-lactating females of non-childbearing potential. Female patients should be either post-menopausal or surgically sterile.
- Age ≥18 and ≤55 years.
- Body mass index (BMI) of 18.5 to 34.0 kg/m2, inclusive, and a total body weight of >50kg (110 pounds).
- In good health as determined by medical history, a baseline physical examination, vital signs, clinical laboratory tests and electrocardiogram (ECG) measurement.
- Subject is willing and able to sign written informed consent prior to receipt of any study medication or beginning study procedures.
Key exclusion criteria (16 listed)
- Pregnant or lactating females, or females of childbearing potential.
- Subject is positive for HIV, hepatitis B surface antigen or hepatitis C antibody tests at screening.
- Subject with a positive urine test for drugs of abuse or alcohol at screening or at admission to the clinic on study Day -1.
- Evidence of any out-of range laboratory value at screening that has not been reviewed, approved and documented as not clinically significant by the Principal Investigator.
- Subject who has resting supine blood pressure outside of a systolic blood pressure range of 90-140 mmHg or a diastolic blood pressure outside a range of 50-90 mmHg on two consecutive measurements taken up to 10 minutes apart.
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 |
|---|---|---|
| SRX246single oral dose of SRX246 capsule | Drug | Active |
| PlaceboSingle oral dose of placebo capsule | Drug | Placebo |
Primary outcome
To assess safety and tolerability of SRX246 at single doses ranging between 20 and 360 mg
Time frame: 24 hours
1 secondary outcome
To assess Pharmacokinetics of SRX246 at single doses ranging between 20 and 360 mg
Time frame: 24 hours
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 17 Mar 2010.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Benno G Roesch, MD principal investigator
Advanced Biomedical Research
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 SRX246 in people with Healthy, run by Azevan 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 6 inclusion and 16 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 17 Mar 2010. 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?
To assess safety and tolerability of SRX246 at single doses ranging between 20 and 360 mg (time frame: 24 hours). 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 17 Mar 2010.