Healthy VolunteersPhase 1NCT02155504
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP3700 in Healthy Male Subjects
A Phase 1 study testing ASP3700 and itraconazole in people with Healthy Volunteers and Pharmacokinetics of ASP3700, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of ASP3700 in healthy male subjects. This study will also explore the effect of itraconazole (another drug) on the PK of ASP3700, as well as to evaluate the safety and tolerability of ASP3700… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Pharmacokinetics of ASP3700
- What is being tested?
- ASP3700 and itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to Oct 2014
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject has a body mass index range of 18.5 - 30.0 kg/m2. The subject weighs at least 50 kg.
- Subject and his female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continue throughout the clinical study period and for 90 days after the final study drug administration.
- Subject must not donate sperm starting at screening and throughout the clinical study period and for 90 days after the final study drug administration.
Who cannot join
- Subject has a known or suspected hypersensitivity to ASP3700 (parts 1 and 2) or itraconazole (part 2 only) or significant adverse reactions to historical cannabinoid use or any components of the formulations used.
- Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, gamma-glutamyl transaminase, total bilirubin [TBL]) above the upper limit of normal (ULN). In such a case the assessment may be repeated once (upon admission to the clinical unit).
- Subject has a history of a suicide attempt or suicidal behavior. Any recent suicidal ideation within the last 3 months or who are at significant risk to commit suicide, as judged by the Investigator using the C-SSRS (a level of 4 or 5) at screening or upon admission to the clinical unit.
- Subject has any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests at screening or upon admission to the clinical unit.
- Subject has a pulse rate < 40 or > 90 beats per minute; mean SBP > 140 mmHg; mean DBP > 90 mmHg (vital signs measurements taken in triplicate after subject has been resting in supine position for 5 minutes; pulse rate will be measured automatically) upon admission to the clinical unit.
- Subject has a mean corrected QT interval using Fridericia's formula (QTcF) interval > 430 ms at day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG can be taken.
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- Subject has a history of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the clinical unit.
- Subject has a history of drinking more than 21 units of alcohol per week (1 unit = 10 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine [12%]) within 3 months prior to admission to the clinical unit.
- Subject has consumed grapefruit, grapefruit-containing products or Seville orange-containing products within 72 hours prior to admission to the clinical unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP3700 in Healthy Male Subjects, Including a Drug-drug Interaction Part With Itraconazole
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of ASP3700 in healthy male subjects. This study will also explore the effect of itraconazole (another drug) on the PK of ASP3700, as well as to evaluate the safety and tolerability of ASP3700 alone and in combination with itraconazole in healthy male subjects.
Read the detailed description
This study consists of 2 parts: Part 1 is a single ascending dose study where subjects will receive either ASP3700 or matching placebo; Part 2 is a drug-drug interaction (DDI) open-label, crossover study comprised of 1 sequence with 2 investigational periods where subjects will receive ASP3700 alone and in combination with itraconazole.
- Conditions
- Healthy Volunteers, Pharmacokinetics of ASP3700
- Being tested
- ASP3700, itraconazole, Placebo
- Keywords
- Healthy volunteers, Pharmacokinetics, ASP3700, Itraconazole, Drug-drug interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP3700Drug
oral
itraconazoleDrug
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| ASP3700 single ascending dose cohort | Experimental | Part 1 Receives: Drug: ASP3700 |
| Placebo single ascending dose cohort | Placebo comparator | Part 1 Receives: Drug: Placebo |
| ASP3700 alone | Experimental | Part 2 Receives: Drug: ASP3700 |
| ASP3700 and itraconazole | Active comparator | Part 2 Receives: Drug: ASP3700; Drug: itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by adverse events (Part 1)
Measured: up to end of study visit (up to 16 days)
Safety as assessed by vital signs (Part 1)
Measured: up to end of study visit (up to 16 days)
Safety as assessed by laboratory tests (Part 1)
Laboratory tests includes the measurement of sex-hormone related biomarkers and exploratory renal biomarkers.
Measured: up to end of study visit (up to 16 days)
Safety as assessed by electrocardiogram (ECG) measurements (Part 1)
ECG measurements include routine 12-lead ECG, continuous cardiac monitoring (Holter ECG) and real-time cardiac monitoring (ECG telemetry)
Measured: up to end of study visit (up to 16 days)
Safety as assessed by Bond and Lader VAS (Part 1)
visual analogue scale (VAS)
Measured: Up to Day 2
Safety as assessed by C-SSRS (Part 1)
Columbia - Suicide Severity Rating Scale (C-SSRS)
Measured: Up to end of study visit (up to 16 days)
Safety as assessed by ARCI-49 (Part 1)
Addiction Research Center Inventory (ARCI)-49 (49-item)
Measured: Up to Day 2
Pharmacokinetic parameter of itraconazole (plasma): Ctrough (Part 2)
Concentration immediately prior to dosing at multiple dosing
Measured: Days 3-13
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): AUCinf (Part 2)
Area under the concentration-time curve from time of dosing extrapolated to time infinity (AUCinf)
Measured: Days 1-7 (period 1) and Days 1-13 (period 2)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): AUCinf (%extrap) (Part 2)
Percentage of AUCinf due to extrapolation from tlast to time infinity (AUCinf [%extrap])
Measured: Days 1-7 (period 1) and Days 1-13 (period 2)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): AUClast (Part 2)
Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
Measured: Days 1-7 (period 1) and Days 1-13 (period 2)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): Cmax (Part 2)
Maximum concentration (Cmax)
Measured: Days 1-7 (period 1) and Days 1-13 (period 2)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma):λz (Part 2)
Terminal elimination rate constant (λz)
Measured: Days 1-7 (period 1) and Days 1-13 (period 2)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): MRT (Part 2)
Mean residence time (MRT)
Measured: Days 1-7 (period 1) and Days 1-13 (period 2)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): tlag (Part 2)
Time prior to the time corresponding to the first measurable (nonzero) concentration (tlag)
Measured: Day 1 (period 1 and 2)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): tmax (Part 2)
Time of maximum concentration (tmax)
Measured: Days 1-7 (period 1) and Days 1-13 (period 2)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): t1/2 (Part 2)
Terminal elimination half-life (t1/2)
Measured: Days 1-7 (period 1) and Days 1-13 (period 2)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): Vz/F (Part 2)
Apparent volume of distribution during the terminal elimination phase after extravascular dosing (Vz/F)
Measured: Days 1-7 (period 1) and Days 1-13 (period 2)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): Aelast (Part 2)
Cumulative amount of study drug excreted into urine from time of dosing up to the collection time of the last measurable concentration (Aelast)
Measured: Days 1-7 (period 1) and Days 1-13 (period 2)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): Aeinf (Part 2)
Cumulative amount of study drug excreted into urine from time of dosing extrapolated to time infinity (Aeinf)
Measured: Days 1-7 (period 1) and Days 1-13 (period 2)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): Aelast% (Part 2)
Percentage of study drug excreted into urine from the time of dosing up to the collection time of the last measurable concentration (Aelast%)
Measured: Days 1-7 (period 1) and Days 1-13 (period 2)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): Aeinf% (Part 2)
Percentage of study drug excreted into urine from time of dosing extrapolated to time infinity (Aeinf%)
Measured: Days 1-7 (period 1) and Days 1-13 (period 2)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): CLR (Part 2)
Renal clearance (CLR)
Measured: Days 1-7 (period 1) and Days 1-13 (period 2)
Safety as assessed by orthostatic evaluation (or blood pressure change in orthostatic challenge test) (Part 1)
Measured: Up to Day 7
Secondary outcomes (3)
Composite of pharmacokinetics of ASP3700: AUCinf, AUCinf(%extrap), AUClast, Cmax, CL/F, λz, MRT, tlag, tmax, t½, Vz/F (plasma) (Part 1)
Measured: up to Day 7
Title: Composite of pharmacokinetics of ASP3700: Aelast, Aeinf, Aelast%, Aeinf%, CLR (urine) (Part 1)
Measured: up to Day 7
Safety as assessed by adverse events, vital signs, orthostatic evaluation, laboratory tests, ECG measurements, C-SSRS, Bond & Lader VAS, ARCI-49 (Part 2)
Measured: Days 1-7 (period 1) and Days 1-13 (period 2) and at end of study visit (up to 22 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155504
- Sponsor's protocol ID
- 3700-CL-0001
- Other IDs
- 2013-005018-36
- Status last verified
- Oct 2014
- First submitted
- 28 May 2014
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP3700 in Healthy Male Subjects, Including a Drug-drug Interaction Part With Itraconazole
- ClinicalTrials.gov ID
- NCT02155504
- Acronym / sponsor ID
- 3700-CL-0001
- Conditions
- Healthy Volunteers, Pharmacokinetics of ASP3700
- Keywords
- Healthy volunteers, Pharmacokinetics, ASP3700, Itraconazole, Drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 Jun 2014 (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.
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of ASP3700 in healthy male subjects. This study will also explore the effect of itraconazole (another drug) on the PK of ASP3700, as well as to evaluate the safety and tolerability of ASP3700 alone and in combination with itraconazole in healthy male subjects.
Detailed description
This study consists of 2 parts: Part 1 is a single ascending dose study where subjects will receive either ASP3700 or matching placebo; Part 2 is a drug-drug interaction (DDI) open-label, crossover study comprised of 1 sequence with 2 investigational periods where subjects will receive ASP3700 alone and in combination with itraconazole.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASP3700 single ascending dose cohort | Experimental | Drug: ASP3700Part 1 |
| Placebo single ascending dose cohort | Placebo comparator | Drug: PlaceboPart 1 |
| ASP3700 alone | Experimental | Drug: ASP3700Part 2 |
| ASP3700 and itraconazole | Active comparator | Drug: ASP3700, Drug: itraconazolePart 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject has a body mass index range of 18.5 - 30.0 kg/m2. The subject weighs at least 50 kg.
- Subject and his female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continue throughout the clinical study period and for 90 days after the final study drug administration.
- Subject must not donate sperm starting at screening and throughout the clinical study period and for 90 days after the final study drug administration.
Key exclusion criteria (9 listed)
- Subject has a known or suspected hypersensitivity to ASP3700 (parts 1 and 2) or itraconazole (part 2 only) or significant adverse reactions to historical cannabinoid use or any components of the formulations used.
- Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, gamma-glutamyl transaminase, total bilirubin [TBL]) above the upper limit of normal (ULN). In such a case the assessment may be repeated once (upon admission to the clinical unit).
- Subject has a history of a suicide attempt or suicidal behavior. Any recent suicidal ideation within the last 3 months or who are at significant risk to commit suicide, as judged by the Investigator using the C-SSRS (a level of 4 or 5) at screening or upon admission to the clinical unit.
- Subject has any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests at screening or upon admission to the clinical unit.
- Subject has a pulse rate < 40 or > 90 beats per minute; mean SBP > 140 mmHg; mean DBP > 90 mmHg (vital signs measurements taken in triplicate after subject has been resting in supine position for 5 minutes; pulse rate will be measured automatically) upon admission to the clinical unit.
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 |
|---|---|---|
| ASP3700oral | Drug | ASP3700 alone, ASP3700 and itraconazole, ASP3700 single ascending dose cohort |
| itraconazoleoral | Drug | ASP3700 and itraconazole |
| Placebooral | Drug | Placebo single ascending dose cohort |
Primary outcome
Safety as assessed by adverse events (Part 1)
Time frame: up to end of study visit (up to 16 days)
Safety as assessed by vital signs (Part 1)
Time frame: up to end of study visit (up to 16 days)
Safety as assessed by laboratory tests (Part 1)
Time frame: up to end of study visit (up to 16 days)
Laboratory tests includes the measurement of sex-hormone related biomarkers and exploratory renal biomarkers.
Safety as assessed by electrocardiogram (ECG) measurements (Part 1)
Time frame: up to end of study visit (up to 16 days)
ECG measurements include routine 12-lead ECG, continuous cardiac monitoring (Holter ECG) and real-time cardiac monitoring (ECG telemetry)
Safety as assessed by Bond and Lader VAS (Part 1)
Time frame: Up to Day 2
visual analogue scale (VAS)
Safety as assessed by C-SSRS (Part 1)
Time frame: Up to end of study visit (up to 16 days)
Columbia - Suicide Severity Rating Scale (C-SSRS)
Safety as assessed by ARCI-49 (Part 1)
Time frame: Up to Day 2
Addiction Research Center Inventory (ARCI)-49 (49-item)
Pharmacokinetic parameter of itraconazole (plasma): Ctrough (Part 2)
Time frame: Days 3-13
Concentration immediately prior to dosing at multiple dosing
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): AUCinf (Part 2)
Time frame: Days 1-7 (period 1) and Days 1-13 (period 2)
Area under the concentration-time curve from time of dosing extrapolated to time infinity (AUCinf)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): AUCinf (%extrap) (Part 2)
Time frame: Days 1-7 (period 1) and Days 1-13 (period 2)
Percentage of AUCinf due to extrapolation from tlast to time infinity (AUCinf [%extrap])
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): AUClast (Part 2)
Time frame: Days 1-7 (period 1) and Days 1-13 (period 2)
Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): Cmax (Part 2)
Time frame: Days 1-7 (period 1) and Days 1-13 (period 2)
Maximum concentration (Cmax)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma):λz (Part 2)
Time frame: Days 1-7 (period 1) and Days 1-13 (period 2)
Terminal elimination rate constant (λz)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): MRT (Part 2)
Time frame: Days 1-7 (period 1) and Days 1-13 (period 2)
Mean residence time (MRT)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): tlag (Part 2)
Time frame: Day 1 (period 1 and 2)
Time prior to the time corresponding to the first measurable (nonzero) concentration (tlag)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): tmax (Part 2)
Time frame: Days 1-7 (period 1) and Days 1-13 (period 2)
Time of maximum concentration (tmax)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): t1/2 (Part 2)
Time frame: Days 1-7 (period 1) and Days 1-13 (period 2)
Terminal elimination half-life (t1/2)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): Vz/F (Part 2)
Time frame: Days 1-7 (period 1) and Days 1-13 (period 2)
Apparent volume of distribution during the terminal elimination phase after extravascular dosing (Vz/F)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): Aelast (Part 2)
Time frame: Days 1-7 (period 1) and Days 1-13 (period 2)
Cumulative amount of study drug excreted into urine from time of dosing up to the collection time of the last measurable concentration (Aelast)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): Aeinf (Part 2)
Time frame: Days 1-7 (period 1) and Days 1-13 (period 2)
Cumulative amount of study drug excreted into urine from time of dosing extrapolated to time infinity (Aeinf)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): Aelast% (Part 2)
Time frame: Days 1-7 (period 1) and Days 1-13 (period 2)
Percentage of study drug excreted into urine from the time of dosing up to the collection time of the last measurable concentration (Aelast%)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): Aeinf% (Part 2)
Time frame: Days 1-7 (period 1) and Days 1-13 (period 2)
Percentage of study drug excreted into urine from time of dosing extrapolated to time infinity (Aeinf%)
Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): CLR (Part 2)
Time frame: Days 1-7 (period 1) and Days 1-13 (period 2)
Renal clearance (CLR)
Safety as assessed by orthostatic evaluation (or blood pressure change in orthostatic challenge test) (Part 1)
Time frame: Up to Day 7
3 secondary outcomes
Composite of pharmacokinetics of ASP3700: AUCinf, AUCinf(%extrap), AUClast, Cmax, CL/F, λz, MRT, tlag, tmax, t½, Vz/F (plasma) (Part 1)
Time frame: up to Day 7
Title: Composite of pharmacokinetics of ASP3700: Aelast, Aeinf, Aelast%, Aeinf%, CLR (urine) (Part 1)
Time frame: up to Day 7
Safety as assessed by adverse events, vital signs, orthostatic evaluation, laboratory tests, ECG measurements, C-SSRS, Bond & Lader VAS, ARCI-49 (Part 2)
Time frame: Days 1-7 (period 1) and Days 1-13 (period 2) and at end of study visit (up to 22 days)
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 Oct 2014.
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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.
Medical Director study director
Astellas Pharma Europe B.V.
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 ASP3700 and itraconazole in people with Healthy Volunteers and Pharmacokinetics of ASP3700, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.
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 3 inclusion and 9 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 Oct 2014. 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 Kingdom. 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?
Safety as assessed by adverse events (Part 1) (time frame: up to end of study visit (up to 16 days)). The study lists 24 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 Oct 2014.