Healthy VolunteersPhase 1NCT02981290

Study to Compare the Pharmacokinetics of Mycophenolate Mofetil Metabolites From Four Tablet Formulations in Healthy Participants

A Phase 1 study testing Renodapt, Mycept and Cellmune in people with Healthy Volunteers, run by Hoffmann-La Roche at 1 site in New Zealand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single center, randomized, open label, 4-treatment, 4-period, 4-sequence, 4-way crossover study to compare the pharmacokinetics of mycophenolate mofetil (MMF) metabolites from 4 tablet formulations in healthy participants. 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
What is being tested?: Renodapt, Mycept and Cellmune
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteNew Zealand
Study dates: Jul 2008to Oct 2008
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

A body mass index (BMI) between 18 and 32 kilogram per meter square (kg/m^2)

Who cannot join

Any evidence of clinically significant allergic, renal, cardiac, bronchopulmonary, vascular, gastro-intestinal, neurological, metabolic or immunodeficiency disorders, cancer, hepatitis or cirrhosis
Any evidence of gall bladder surgery, surgery of the gastro-intestinal tract or any other medical condition considered likely to affect drug absorption
Any major illness within 2 months prior to first dosing or febrile illness within 14 days prior to first dosing
Any known history of clinically significant allergic reactions or drug hypersensitivity, especially hypersensitivity to MMF or mycophenolic acid (MPA)
Any other ongoing concomitant disease or condition that could interfere with, or the treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participants
Any prescribed or over-the-counter (OTC) medication, herbal medicine or dietary aid taken within 2 weeks before the first study drug dosing or within six times the elimination half-life of the medication before the first study drug dosing

Trial locations and contacts

1 site in 1 country.

New Zealand1 site

Christchurch Clinical Studies Trust
Christchurch

Other trials in New Zealand

About this study

Official title: A Randomized, Open Label, Four-way Crossover Study to Compare the Pharmacokinetics of Mycophenolate Mofetil Metabolites From Four Tablet Formulations in Healthy Subjects

Conditions: Healthy Volunteers
Being tested: Renodapt, Mycept, Cellmune, CellCept

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RenodaptDrug
Renodapt will be administered as 500 milligrams (mg) tablet orally on Day 1 in any treatment periods.
MyceptDrug
Mycept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
CellmuneDrug
Cellmune will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
CellCeptDrug
CellCept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.

Study groups in NCT02981290
Study group	Role	What they receive
Renodapt Then Mycept Then Cellmune Then CellCept	Experimental	Participants will receive Renodapt in first treatment period (each treatment period= 3 days) followed by Mycept in second treatment period then Cellmune in third treatment period and CellCept in fourth treatment period. A washout period of 7 days will be separating each treatment period. Receives: Drug: Renodapt; Drug: Mycept; Drug: Cellmune; Drug: CellCept
Mycept Then CellCept Then Renodapt Then Cellmune	Experimental	Participants will receive Mycept in first treatment period (each treatment period= 3 days) followed by CellCept in second treatment period then Renodapt in third treatment period and Cellmune in fourth treatment period. A washout period of 7 days will be separating each treatment period. Receives: Drug: Renodapt; Drug: Mycept; Drug: Cellmune; Drug: CellCept
Cellmune Then Renodapt Then CellCept Then Mycept	Experimental	Participants will receive Cellmune in first treatment period (each treatment period= 3 days) followed by Renodapt in second treatment period then CellCept in third treatment period and Mycept in fourth treatment period. A washout period of 7 days will be separating each treatment period. Receives: Drug: Renodapt; Drug: Mycept; Drug: Cellmune; Drug: CellCept
CellCept Then Cellmune Then Mycept Then Renodapt	Experimental	Participants will receive CellCept in first treatment period (each treatment period= 3 days) followed by Cellmune in second treatment period then Mycept in third treatment period and Renodapt in fourth treatment period. A washout period of 7 days will be separating each treatment period. Receives: Drug: Renodapt; Drug: Mycept; Drug: Cellmune; Drug: CellCept

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of MPA
Measured: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of MPA
Measured: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Maximum Observed Plasma Concentration (Cmax) of MPA
Measured: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of MPA
Measured: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Absorption Lag Time (Tlag) of MPA
Measured: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Plasma Terminal Half-Life (t1/2) of MPA
Measured: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Apparent Oral Clearance (CL/F) of MPA
Measured: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1

Secondary outcomes (10)

Apparent Oral Volume of Distribution (V/F) of MPA
Measured: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
AUC (0-inf) of the Glucuronide Metabolite of MPA (MPAG)
Measured: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
AUClast of MPAG
Measured: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Cmax of MPAG
Measured: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Tmax of MPAG
Measured: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Tlag of MPAG
Measured: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
t1/2 of MPAG
Measured: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
CL/F of MPAG
Measured: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
V/F of MPAG
Measured: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Baseline up to 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Oct 2008

First posted5 Dec 2016 (estimated)
Study startJul 2008
Primary completionOct 2008
Study completionOct 2008

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 Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02981290
Sponsor's protocol ID: WP21980
Status last verified: Dec 2016
First submitted: 1 Dec 2016
Last updated: 5 Dec 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Reigner B, Grange S, Bentley D, Banken L, Abt M, Hughes R, Scheubel E, Guentert TW. Generics in transplantation medicine: Randomized comparison of innovator and substitution products containing mycophenolate mofetil . Int J Clin Pharmacol Ther. 2019 Oct;57(10):506-519. doi: 10.5414/CP203487.
PubMed 31397274

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open Label, Four-way Crossover Study to Compare the Pharmacokinetics of Mycophenolate Mofetil Metabolites From Four Tablet Formulations in Healthy Subjects
ClinicalTrials.gov ID: NCT02981290
Acronym / sponsor ID: WP21980
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 5 Dec 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Renodapt Then Mycept Then Cellmune Then CellCept	Experimental	Drug: Renodapt, Drug: Mycept, Drug: Cellmune, Drug: CellCeptParticipants will receive Renodapt in first treatment period (each treatment period= 3 days) followed by Mycept in second treatment period then Cellmune in third treatment period and CellCept in fourth treatment period. A washout period of 7 days will be separating each treatment period.
Mycept Then CellCept Then Renodapt Then Cellmune	Experimental	Drug: Renodapt, Drug: Mycept, Drug: Cellmune, Drug: CellCeptParticipants will receive Mycept in first treatment period (each treatment period= 3 days) followed by CellCept in second treatment period then Renodapt in third treatment period and Cellmune in fourth treatment period. A washout period of 7 days will be separating each treatment period.
Cellmune Then Renodapt Then CellCept Then Mycept	Experimental	Drug: Renodapt, Drug: Mycept, Drug: Cellmune, Drug: CellCeptParticipants will receive Cellmune in first treatment period (each treatment period= 3 days) followed by Renodapt in second treatment period then CellCept in third treatment period and Mycept in fourth treatment period. A washout period of 7 days will be separating each treatment period.
CellCept Then Cellmune Then Mycept Then Renodapt	Experimental	Drug: Renodapt, Drug: Mycept, Drug: Cellmune, Drug: CellCeptParticipants will receive CellCept in first treatment period (each treatment period= 3 days) followed by Cellmune in second treatment period then Mycept in third treatment period and Renodapt in fourth treatment period. A washout period of 7 days will be separating each treatment period.

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

A body mass index (BMI) between 18 and 32 kilogram per meter square (kg/m^2)

Key exclusion criteria (6 listed)

Any evidence of clinically significant allergic, renal, cardiac, bronchopulmonary, vascular, gastro-intestinal, neurological, metabolic or immunodeficiency disorders, cancer, hepatitis or cirrhosis
Any evidence of gall bladder surgery, surgery of the gastro-intestinal tract or any other medical condition considered likely to affect drug absorption
Any major illness within 2 months prior to first dosing or febrile illness within 14 days prior to first dosing
Any known history of clinically significant allergic reactions or drug hypersensitivity, especially hypersensitivity to MMF or mycophenolic acid (MPA)
Any other ongoing concomitant disease or condition that could interfere with, or the treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participants

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
RenodaptRenodapt will be administered as 500 milligrams (mg) tablet orally on Day 1 in any treatment periods.	Drug	CellCept Then Cellmune Then Mycept Then Renodapt, Cellmune Then Renodapt Then CellCept Then Mycept, Mycept Then CellCept Then Renodapt Then Cellmune, Renodapt Then Mycept Then Cellmune Then CellCept
MyceptMycept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.	Drug	CellCept Then Cellmune Then Mycept Then Renodapt, Cellmune Then Renodapt Then CellCept Then Mycept, Mycept Then CellCept Then Renodapt Then Cellmune, Renodapt Then Mycept Then Cellmune Then CellCept
CellmuneCellmune will be administered as 500 mg tablet orally on Day 1 in any treatment periods.	Drug	CellCept Then Cellmune Then Mycept Then Renodapt, Cellmune Then Renodapt Then CellCept Then Mycept, Mycept Then CellCept Then Renodapt Then Cellmune, Renodapt Then Mycept Then Cellmune Then CellCept
CellCeptCellCept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.	Drug	CellCept Then Cellmune Then Mycept Then Renodapt, Cellmune Then Renodapt Then CellCept Then Mycept, Mycept Then CellCept Then Renodapt Then Cellmune, Renodapt Then Mycept Then Cellmune Then CellCept

Primary outcome

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of MPA
Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of MPA
Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Maximum Observed Plasma Concentration (Cmax) of MPA
Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of MPA
Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Absorption Lag Time (Tlag) of MPA
Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Plasma Terminal Half-Life (t1/2) of MPA
Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Apparent Oral Clearance (CL/F) of MPA
Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1

10 secondary outcomes

Apparent Oral Volume of Distribution (V/F) of MPA
Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
AUC (0-inf) of the Glucuronide Metabolite of MPA (MPAG)
Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
AUClast of MPAG
Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Cmax of MPAG
Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Tmax of MPAG
Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Tlag of MPAG
Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
t1/2 of MPAG
Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
CL/F of MPAG
Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
V/F of MPAG
Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 9 weeks

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 5 Dec 2016.
Derived from this study: PubMed 31397274Reigner B, Grange S, Bentley D, Banken L, Abt M, Hughes R, Scheubel E, Guentert TW. Generics in transplantation medicine: Randomized comparison of innovator and substitution products containing mycophenolate mofetil . Int J Clin Pharmacol Ther. 2019 Oct;57(10):506-519. doi: 10.5414/CP203487.
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.

Clinical Trials study director

Hoffmann-La Roche

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 Renodapt, Mycept and Cellmune in people with Healthy Volunteers, run by Hoffmann-La Roche at 1 site in New Zealand.

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 6 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 5 Dec 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 New Zealand. 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. 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?

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of MPA (time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1). The study lists 7 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 NCT02981290, 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 5 Dec 2016.