Herpes GenitalisPhase 1NCT02852876
Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food
A Phase 1 study testing ASP2151 in people with Herpes Genitalis and Herpes Zoster, run by Astellas Pharma Europe Ltd. at 1 site in France.
Trial summary
The objective of this study is to evaluate the safety and tolerability of single rising doses of ASP2151 under fasted condition in healthy male subjects. The study will also evaluate the pharmacokinetics (PK) of a single dose of ASP2151 under fasted versus fed conditions in healthy male subjects. 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
- Herpes Genitalis, Herpes Zoster
- What is being tested?
- ASP2151
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2005to Dec 2005
- 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
- Body weight between 60 and 100 kg, and BMI between 18 and 30 kg/m2 inclusive
Who cannot join
- Known or suspected hypersensitivity to ASP2151 or any components of the formulation used
- Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug
- Any clinically significant history of genital herpes symptoms and/or herpes zoster symptoms in the 3 months prior to admission to the Clinical Unit
- Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic
- Abnormal pulse rate and/or blood pressure measurements at the pre-study visit as follows: Pulse rate <40 or >90 bpm (beats per minute); mean systolic blood pressure <90 or >140 mmHg (millimeter of mercury); mean diastolic blood pressure <40 or >95 mmHg
- Regular use of any prescribed or OTC (over the counter) drugs in the 4 weeks prior to admission to the Clinical Unit OR any use of such drugs in the 2 weeks prior to admission to the Clinical Unit
Show all 12Show fewer
- Any use of drugs of abuse within 3 months prior to admission to the Clinical Unit
- History of smoking more than 10 cigarettes per day within 3 months prior to admission to the Clinical Unit
- History of drinking more than 21 units of alcohol per week within 3 months prior to admission to the Clinical Unit
- Donation of blood or blood products within 3 months, prior to admission to the Clinical Unit
- Positive serology test for HBsAg (Hepatitis B surface antigen), HAV IgM (Hepatitis A Virus), anti-HCV (Hepatitis C Virus) or anti-HIV (Human Immunodeficiency Virus) 1 and 2
- Not willing or able to swallow size 00 capsules
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled Single Dose Escalating Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2151 in Healthy Male Subjects, Followed by an Open, Two-Period Crossover Study to Assess the Effect of Fed Conditions on the Safety, Tolerability and Pharmacokinetics of ASP2151
The objective of this study is to evaluate the safety and tolerability of single rising doses of ASP2151 under fasted condition in healthy male subjects.
The study will also evaluate the pharmacokinetics (PK) of a single dose of ASP2151 under fasted versus fed conditions in healthy male subjects.
Read the detailed description
Study will be divided into two parts. Part 1 will evaluate the safety and tolerability of ASP2151 single rising doses in groups A-H in fasted condition and to determine the maximum tolerable dose (MTD) if possible.
Part 2 will evaluate the effect of fasted versus fed conditions on the safety, tolerability and PK of a single dose of ASP2151 in two treatment cycles. The wash-out period between the two treatment cycles will be at least 5 days and not shorter than five times the average elimination half-life of ASP2151, as determined in part 1 of the study.
- Conditions
- Herpes Genitalis, Herpes Zoster
- Being tested
- ASP2151, Placebo
- Keywords
- Safety of ASP2151, Phase 1, Pharmacokinetics, Healthy male subjects, Tolerability, Food effect of ASP2151
- Medical subject headings
- Herpes Genitalis, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP2151Drug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Part 1: ASP2151 Single Ascending Dose Group A (Fasting) | Experimental | Participants will receive single dose of ASP2151 assigned to Group A on day 1 Receives: Drug: ASP2151 |
| Part 1: ASP2151 Single Ascending Dose Group B (Fasting) | Experimental | Participants will receive single dose of ASP2151 assigned to Group B on day 1 Receives: Drug: ASP2151 |
| Part 1: ASP2151 Single Ascending Dose Group C (Fasting) | Experimental | Participants will receive single dose of ASP2151 assigned to Group C on day 1 Receives: Drug: ASP2151 |
| Part 1: ASP2151 Single Ascending Dose Group D (Fasting) | Experimental | Participants will receive single dose of ASP2151 assigned to Group D on day 1 Receives: Drug: ASP2151 |
| Part 1: ASP2151 Single Ascending Dose Group E (Fasting) | Experimental | Participants will receive single dose of ASP2151 assigned to Group E on day 1 Receives: Drug: ASP2151 |
| Part 1: ASP2151 Single Ascending Dose Group F (Fasting) | Experimental | Participants will receive single dose of ASP2151 assigned to Group F on day 1 Receives: Drug: ASP2151 |
| Part 1: Placebo Single Ascending Dose (Fasting) | Placebo comparator | Participants will receive single dose of matching placebo on day 1 Receives: Drug: Placebo |
| Part 2: ASP2151 (Fasting) | Experimental | Participants will receive a single dose of ASP2151 under fasted conditions on day 1 in the first treatment period (period 1). Following a wash-out period of at least five days, the treatment will be repeated in the reverse orientation (period 2) Receives: Drug: ASP2151 |
| Part 2: ASP2151 (Fed) | Experimental | Participants will receive a single dose of ASP2151 under fed conditions on day 1 in the first treatment period (period 1). Following a wash-out period of at least five days, the treatment will be repeated in the reverse orientation (period 2) Receives: Drug: ASP2151 |
| Part 1: ASP2151 Single Ascending Dose Group G (Fasting) | Experimental | Participants will receive single dose of ASP2151 assigned to Group G on day 1 Receives: Drug: ASP2151 |
| Part 1: ASP2151 Single Ascending Dose Group H (Fasting) | Experimental | Participants will receive single dose of ASP2151 assigned to Group H on day 1 Receives: Drug: ASP2151 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)
For Part 1 and Part 2
Measured: Up to Day 15 of each treatment period
Safety assessed by 12- lead electrocardiogram (ECG)
For Part 1 and Part 2
Measured: Up to Day 15 of each treatment period
Safety assessed by vital sign measurement: blood pressure
For Part 1 and Part 2 includes systolic and blood diastolic pressure
Measured: Up to Day 15 of each treatment period
Safety assessed by vital sign measurement: pulse rate
For Part 1 and Part 2
Measured: Up to Day 15 of each treatment period
Safety assessed by laboratory test: biochemical
For Part 1 and Part 2
Measured: Up to Day 15 of each treatment period
Safety assessed by laboratory test: hematological
For Part 1 and Part 2
Measured: Up to Day 15 of each treatment period
Safety assessed by laboratory test: serology
For Part 1 and Part 2
Measured: Up to Day 15 of each treatment period
Safety assessed by laboratory test: urinalysis
For Part 1 and Part 2
Measured: Up to Day 15 of each treatment period
Safety assessed by physical exam: body weight
For Part 1 and Part 2
Measured: Up to Day 15 of each treatment period
Safety assessed by physical exam: height
For Part 1 and Part 2
Measured: Up to Day 15 of each treatment period
Safety assessed by physical exam: body mass index (BMI)
For Part 1 and Part 2
Measured: Up to Day 15 of each treatment period
Secondary outcomes (12)
Pharmacokinetics of ASP2151 in plasma: AUC0-inf
For Part 1 and 2. AUC0-inf: Area under the concentration time curve from the time of dosing extrapolated to time infinity
Measured: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in plasma: t1/2
For Part 1 and 2. t1/2: Apparent terminal elimination half-life
Measured: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in plasma: Cmax
For Part 1 and 2. Cmax: Maximum concentration
Measured: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in plasma: tmax
For Part 1 and 2. tmax: The time after dosing when Cmax occurs
Measured: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in plasma: CL/F
For Part 1 and 2. CL/F: Oral clearance
Measured: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in plasma: Vz/F
For Part 1 and 2. Vz/F: Apparent volume of distribution
Measured: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in plasma: AUClast
For Part 1 and 2. AUClast: Area under the plasma concentration time curve from time of dosing up to the last quantifiable sample
Measured: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in plasma: tlag
For Part 1 and 2. tlag: Absorption lag time
Measured: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in urine: Aelast
For Part 1 and 2. Aelast: Amount excreted unchanged in urine from time of dosing up to the last quantifiable sample
Measured: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in urine: Ae0-inf
For Part 1 and 2. Ae0-inf: Amount excreted unchanged in urine from time of dosing extrapolated to infinity
Measured: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in urine: Ae%
For Part 1 and 2. Ae%: Percent of ASP2151 amount excreted in urine
Measured: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in urine: CLr
For Part 1 and 2. CLr: Renal clearance
Measured: Up to 48 hours in each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startSep 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes GenitalisStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Clinical Pharmacology & Exploratory Dev.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852876
- Sponsor's protocol ID
- 15L-CL-002
- Other IDs
- 2005-002697-30, 2005
- Status last verified
- Jul 2016
- First submitted
- 29 Jul 2016
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kusawake T, Keirns JJ, Kowalski D, den Adel M, Groenendaal-van de Meent D, Takada A, Ohtsu Y, Katashima M. Pharmacokinetics and Safety of Amenamevir in Healthy Subjects: Analysis of Four Randomized Phase 1 Studies. Adv Ther. 2017 Dec;34(12):2625-2637. doi: 10.1007/s12325-017-0642-4. Epub 2017 Nov 13.
PubMed 29134426
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Single Dose Escalating Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2151 in Healthy Male Subjects, Followed by an Open, Two-Period Crossover Study to Assess the Effect of Fed Conditions on the Safety, Tolerability and Pharmacokinetics of ASP2151
- ClinicalTrials.gov ID
- NCT02852876
- Acronym / sponsor ID
- 15L-CL-002
- Conditions
- Herpes Genitalis, Herpes Zoster
- Keywords
- Safety of ASP2151, Phase 1, Pharmacokinetics, Healthy male subjects, Tolerability, Food effect of ASP2151
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Astellas Pharma Europe Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 2 Aug 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.
The objective of this study is to evaluate the safety and tolerability of single rising doses of ASP2151 under fasted condition in healthy male subjects.
The study will also evaluate the pharmacokinetics (PK) of a single dose of ASP2151 under fasted versus fed conditions in healthy male subjects.
Detailed description
Study will be divided into two parts. Part 1 will evaluate the safety and tolerability of ASP2151 single rising doses in groups A-H in fasted condition and to determine the maximum tolerable dose (MTD) if possible.
Part 2 will evaluate the effect of fasted versus fed conditions on the safety, tolerability and PK of a single dose of ASP2151 in two treatment cycles. The wash-out period between the two treatment cycles will be at least 5 days and not shorter than five times the average elimination half-life of ASP2151, as determined in part 1 of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part 1: ASP2151 Single Ascending Dose Group A (Fasting) | Experimental | Drug: ASP2151Participants will receive single dose of ASP2151 assigned to Group A on day 1 |
| Part 1: ASP2151 Single Ascending Dose Group B (Fasting) | Experimental | Drug: ASP2151Participants will receive single dose of ASP2151 assigned to Group B on day 1 |
| Part 1: ASP2151 Single Ascending Dose Group C (Fasting) | Experimental | Drug: ASP2151Participants will receive single dose of ASP2151 assigned to Group C on day 1 |
| Part 1: ASP2151 Single Ascending Dose Group D (Fasting) | Experimental | Drug: ASP2151Participants will receive single dose of ASP2151 assigned to Group D on day 1 |
| Part 1: ASP2151 Single Ascending Dose Group E (Fasting) | Experimental | Drug: ASP2151Participants will receive single dose of ASP2151 assigned to Group E on day 1 |
| Part 1: ASP2151 Single Ascending Dose Group F (Fasting) | Experimental | Drug: ASP2151Participants will receive single dose of ASP2151 assigned to Group F on day 1 |
| Part 1: Placebo Single Ascending Dose (Fasting) | Placebo comparator | Drug: PlaceboParticipants will receive single dose of matching placebo on day 1 |
| Part 2: ASP2151 (Fasting) | Experimental | Drug: ASP2151Participants will receive a single dose of ASP2151 under fasted conditions on day 1 in the first treatment period (period 1). Following a wash-out period of at least five days, the treatment will be repeated in the reverse orientation (period 2) |
| Part 2: ASP2151 (Fed) | Experimental | Drug: ASP2151Participants will receive a single dose of ASP2151 under fed conditions on day 1 in the first treatment period (period 1). Following a wash-out period of at least five days, the treatment will be repeated in the reverse orientation (period 2) |
| Part 1: ASP2151 Single Ascending Dose Group G (Fasting) | Experimental | Drug: ASP2151Participants will receive single dose of ASP2151 assigned to Group G on day 1 |
| Part 1: ASP2151 Single Ascending Dose Group H (Fasting) | Experimental | Drug: ASP2151Participants will receive single dose of ASP2151 assigned to Group H on day 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body weight between 60 and 100 kg, and BMI between 18 and 30 kg/m2 inclusive
Key exclusion criteria (12 listed)
- Known or suspected hypersensitivity to ASP2151 or any components of the formulation used
- Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug
- Any clinically significant history of genital herpes symptoms and/or herpes zoster symptoms in the 3 months prior to admission to the Clinical Unit
- Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic
- Abnormal pulse rate and/or blood pressure measurements at the pre-study visit as follows: Pulse rate <40 or >90 bpm (beats per minute); mean systolic blood pressure <90 or >140 mmHg (millimeter of mercury); mean diastolic blood pressure <40 or >95 mmHg
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 |
|---|---|---|
| ASP2151Oral | Drug | Part 1: ASP2151 Single Ascending Dose Group A (Fasting), Part 1: ASP2151 Single Ascending Dose Group B (Fasting), Part 1: ASP2151 Single Ascending Dose Group C (Fasting), Part 1: ASP2151 Single Ascending Dose Group D (Fasting), Part 1: ASP2151 Single Ascending Dose Group E (Fasting), Part 1: ASP2151 Single Ascending Dose Group F (Fasting), Part 1: ASP2151 Single Ascending Dose Group G (Fasting), Part 1: ASP2151 Single Ascending Dose Group H (Fasting), Part 2: ASP2151 (Fasting), Part 2: ASP2151 (Fed) |
| PlaceboOral | Drug | Part 1: Placebo Single Ascending Dose (Fasting) |
Primary outcome
Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)
Time frame: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety assessed by 12- lead electrocardiogram (ECG)
Time frame: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety assessed by vital sign measurement: blood pressure
Time frame: Up to Day 15 of each treatment period
For Part 1 and Part 2 includes systolic and blood diastolic pressure
Safety assessed by vital sign measurement: pulse rate
Time frame: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety assessed by laboratory test: biochemical
Time frame: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety assessed by laboratory test: hematological
Time frame: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety assessed by laboratory test: serology
Time frame: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety assessed by laboratory test: urinalysis
Time frame: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety assessed by physical exam: body weight
Time frame: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety assessed by physical exam: height
Time frame: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety assessed by physical exam: body mass index (BMI)
Time frame: Up to Day 15 of each treatment period
For Part 1 and Part 2
12 secondary outcomes
Pharmacokinetics of ASP2151 in plasma: AUC0-inf
Time frame: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in plasma: t1/2
Time frame: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in plasma: Cmax
Time frame: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in plasma: tmax
Time frame: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in plasma: CL/F
Time frame: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in plasma: Vz/F
Time frame: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in plasma: AUClast
Time frame: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in plasma: tlag
Time frame: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in urine: Aelast
Time frame: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in urine: Ae0-inf
Time frame: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in urine: Ae%
Time frame: Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in urine: CLr
Time frame: Up to 48 hours in each treatment period
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 2 Aug 2016.
- Derived from this study: PubMed 29134426Kusawake T, Keirns JJ, Kowalski D, den Adel M, Groenendaal-van de Meent D, Takada A, Ohtsu Y, Katashima M. Pharmacokinetics and Safety of Amenamevir in Healthy Subjects: Analysis of Four Randomized Phase 1 Studies. Adv Ther. 2017 Dec;34(12):2625-2637. doi: 10.1007/s12325-017-0642-4. Epub 2017 Nov 13.
- Individual participant dataSharing planned: Undecided
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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 Clinical Pharmacology & Exploratory Dev.
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 ASP2151 in people with Herpes Genitalis and Herpes Zoster, run by Astellas Pharma Europe Ltd. at 1 site in France.
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 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 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 France. 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 and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs) (time frame: Up to Day 15 of each treatment period). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02852876, which also lists 1 linked publication.
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 2 Aug 2016.