Diabetes MellitusPhase 4TrelagliptinNCT04374864
Dose Modification Requirement for Trelagliptin in Egyptian Population
A Phase 4 study testing Trelagliptin in people with Diabetes Mellitus, run by British University In Egypt at 1 site in Egypt.
Trial summary
The proposed study will consider the pharmacokinetic evaluation of Trelagliptin after administration to Egyptian volunteers and the results will be compared with the other reported ethnic populations. Read more about this study
- Who is it for?
- Ages 25 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Trelagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 1 Jul 2020
- Phase
- Phase 4
- 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 25 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The good health of the human subjects was confirmed by a complete medical history and physical examination.
Who cannot join
- Patients suffering from any chronic disease other than diabetes will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Nermeen Ashoush, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
The British University in Egypt
Cairo, El Sherouk, 11837
Bassam Ayoub, PhD, 26890000 ext. 184, bassam.ayoub@bue.edu.eg
About this study
Official title: Dose of Trelagliptin for Egyptian Patients Requires no Modification Than Japanese
The proposed study will consider the pharmacokinetic evaluation of Trelagliptin after administration to Egyptian volunteers and the results will be compared with the other reported ethnic populations. The FDA recognizes that standard methods of defining racial subgroups are necessary to compare results across pharmacokinetic studies, and to assess potential subgroup differences. The design of the study is open labeled, one treatment, one period, single dose pharmacokinetic study.
Read the detailed description
The proposed study will consider the pharmacokinetic evaluation of Trelagliptin after administration to Egyptian volunteers and the results will be compared with the other reported ethnic populations. The FDA recognizes that standard methods of defining racial subgroups are necessary to compare results across pharmacokinetic studies, and to assess potential subgroup differences. The design of the study is open labeled, one treatment, one period, single dose pharmacokinetic study. The main pharmacokinetic parameters which are Cmax, Tmax, t1/2, elimination rate constant, AUC0-t and AUC0-inf, will be estimated. Fasting of all volunteers will eliminate the possible interaction from food or caffeine consumption. The pharmacokinetic parameters of Trelagliptin will be studied in healthy human subjects according to the ethical regulations of World Medical Association Declaration of Helsinki (October 1996) and the International Conference of Harmonisation Tripartite Guideline for Good Clinical Practice. Written informed consent was provided (attached and signed by the six volunteers) in order to be approved by the ethics committee of the Faculty of Pharmacy, The British University in Egypt. The good health of the human subjects was confirmed by a complete medical history and physical examination. Samples from six, healthy, adult, male, smoking, Egyptian volunteers (age: 25-39 years, average weight: 89.8 kg, Average BMI: 34.2) will be collected at 0, 0.5, 1, 1.5, 2, 2.5, 3, 8, 24, 48, 72, 96, 120, 144 and 168 hrs to be transferred to heparinized centrifuge tubes in order to be analyzed by LC-MS/MS study (developed \& validated) after single oral dose administration of one Zafatek® tablet nominally containing 50 mg Trelaglipitin. The blood samples (1 mL of each sample) will be centrifuged at 3000 rpm for 5 minutes, The main pharmacokinetic parameters of the study which are Cmax, Tmax, t1/2, elimination rate constant, AUC0-t and AUC0-inf will be estimated, using a validated excel software. Blood glucose level will be determined for all volunteers at different time intervals to monitor any hypoglycemic effect. The study will be conducted as per FDA guidelines. The development of such correlations between trelagliptin concentrations and its pharmacologic responses will enable clinicians to apply pharmacokinetic principles to actual patient situations. The evaluation of safety of the study will be based on monitoring of blood glucose level, vital signs, pulse rate, monitoring of adverse events, and physical examination.
- Conditions
- Diabetes Mellitus
- Being tested
- Trelagliptin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrelagliptinDrug
Anti diabetic
| Study group | Role | What they receive |
|---|---|---|
| Trilaglibtin 50 mg | Experimental | Samples from 6 healthy, adult, male, Egyptian volunteers (age: 25-39 years, average weight: 89.8 kg, average body mass index (BMI): 34.2) were collected at 0, 0.5, 1, 1.5, 2, 2.5, 3, 8, 24, 48, 72, 96, 120, 144 and 168 hrs, transferred to heparinized centrifuge tubes and analyzed with the proposed method after single oral dose administration of one Zafatek® tablet nominally containing 50 mg trilagliptin. Blood samples (1 mL of each sample) were centrifuged at 3000 rpm for 5 min. Receives: Drug: Trelagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
The peak plasma concentration of a drug after administration
Measured: 12 hours
Tmax
Time to reach Cmax.
Measured: 12 hours
Elimination half life
The time required for the concentration of the drug to reach half of its original value.
Measured: 12 hours
Elimination rate constant
The rate at which a drug is removed from the body.
Measured: 12 hours
Area under the curve
The integral of the concentration-time curve
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Mar 2020
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Good health of the human subjects was confirmed with a complete medical history and physical examination. Fasting of all volunteers eliminated the possible interaction from high fat meals. The evaluation of safety of the study was based on monitoring of blood glucose level, vital signs, pulse rate, monitoring of adverse events, and physical examination. Samples from 6 healthy, adult, male, Egyptian volunteers (age: 25-39 years, average weight: 89.8 kg, average body mass index (BMI): 34.2) were collected at 0, 0.5, 1, 1.5, 2, 2.5, 3, 8, 24, 48, 72, 96, 120, 144 and 168 hrs, transferred to heparinized centrifuge tubes and analyzed with the proposed method after single oral dose administration of one Zafatek® tablet nominally containing 50 mg TLN. Blood samples (1 mL of each sample) were centrifuged at 3000 rpm for 5 min.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Nermeen Ashoush, Shereen Mowaka, Mariam M. Tadros
- Responsible party
- Principal investigator, Bassam Mahfouz Ayoub, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374864
- Sponsor's protocol ID
- BUE 2020
- Acronym
- Trelagliptin
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose of Trelagliptin for Egyptian Patients Requires no Modification Than Japanese
- ClinicalTrials.gov ID
- NCT04374864
- Acronym / sponsor ID
- Trelagliptin / BUE 2020
- Conditions
- Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Collaborators
- Nermeen Ashoush, Shereen Mowaka, Mariam M. Tadros
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 5 May 2020 (actual)
- 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 proposed study will consider the pharmacokinetic evaluation of Trelagliptin after administration to Egyptian volunteers and the results will be compared with the other reported ethnic populations. The FDA recognizes that standard methods of defining racial subgroups are necessary to compare results across pharmacokinetic studies, and to assess potential subgroup differences. The design of the study is open labeled, one treatment, one period, single dose pharmacokinetic study.
Detailed description
The proposed study will consider the pharmacokinetic evaluation of Trelagliptin after administration to Egyptian volunteers and the results will be compared with the other reported ethnic populations. The FDA recognizes that standard methods of defining racial subgroups are necessary to compare results across pharmacokinetic studies, and to assess potential subgroup differences. The design of the study is open labeled, one treatment, one period, single dose pharmacokinetic study. The main pharmacokinetic parameters which are Cmax, Tmax, t1/2, elimination rate constant, AUC0-t and AUC0-inf, will be estimated. Fasting of all volunteers will eliminate the possible interaction from food or caffeine consumption. The pharmacokinetic parameters of Trelagliptin will be studied in healthy human subjects according to the ethical regulations of World Medical Association Declaration of Helsinki (October 1996) and the International Conference of Harmonisation Tripartite Guideline for Good Clinical Practice. Written informed consent was provided (attached and signed by the six volunteers) in order to be approved by the ethics committee of the Faculty of Pharmacy, The British University in Egypt. The good health of the human subjects was confirmed by a complete medical history and physical examination. Samples from six, healthy, adult, male, smoking, Egyptian volunteers (age: 25-39 years, average weight: 89.8 kg, Average BMI: 34.2) will be collected at 0, 0.5, 1, 1.5, 2, 2.5, 3, 8, 24, 48, 72, 96, 120, 144 and 168 hrs to be transferred to heparinized centrifuge tubes in order to be analyzed by LC-MS/MS study (developed \& validated) after single oral dose administration of one Zafatek® tablet nominally containing 50 mg Trelaglipitin. The blood samples (1 mL of each sample) will be centrifuged at 3000 rpm for 5 minutes, The main pharmacokinetic parameters of the study which are Cmax, Tmax, t1/2, elimination rate constant, AUC0-t and AUC0-inf will be estimated, using a validated excel software. Blood glucose level will be determined for all volunteers at different time intervals to monitor any hypoglycemic effect. The study will be conducted as per FDA guidelines. The development of such correlations between trelagliptin concentrations and its pharmacologic responses will enable clinicians to apply pharmacokinetic principles to actual patient situations. The evaluation of safety of the study will be based on monitoring of blood glucose level, vital signs, pulse rate, monitoring of adverse events, and physical examination.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Good health of the human subjects was confirmed with a complete medical history and physical examination. Fasting of all volunteers eliminated the possible interaction from high fat meals. The evaluation of safety of the study was based on monitoring of blood glucose level, vital signs, pulse rate, monitoring of adverse events, and physical examination. Samples from 6 healthy, adult, male, Egyptian volunteers (age: 25-39 years, average weight: 89.8 kg, average body mass index (BMI): 34.2) were collected at 0, 0.5, 1, 1.5, 2, 2.5, 3, 8, 24, 48, 72, 96, 120, 144 and 168 hrs, transferred to heparinized centrifuge tubes and analyzed with the proposed method after single oral dose administration of one Zafatek® tablet nominally containing 50 mg TLN. Blood samples (1 mL of each sample) were centrifuged at 3000 rpm for 5 min.
| Arm | Type | Receives |
|---|---|---|
| Trilaglibtin 50 mg | Experimental | Drug: TrelagliptinSamples from 6 healthy, adult, male, Egyptian volunteers (age: 25-39 years, average weight: 89.8 kg, average body mass index (BMI): 34.2) were collected at 0, 0.5, 1, 1.5, 2, 2.5, 3, 8, 24, 48, 72, 96, 120, 144 and 168 hrs, transferred to heparinized centrifuge tubes and analyzed with the proposed method after single oral dose administration of one Zafatek® tablet nominally containing 50 mg trilagliptin. Blood samples (1 mL of each sample) were centrifuged at 3000 rpm for 5 min. |
Who may qualify
- Ages
- 25 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The good health of the human subjects was confirmed by a complete medical history and physical examination.
Key exclusion criteria (1 listed)
- Patients suffering from any chronic disease other than diabetes will be excluded from the study.
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 |
|---|---|---|
| TrelagliptinAnti diabetic | Drug | Trilaglibtin 50 mg |
Primary outcome
Cmax
Time frame: 12 hours
The peak plasma concentration of a drug after administration
Tmax
Time frame: 12 hours
Time to reach Cmax.
Elimination half life
Time frame: 12 hours
The time required for the concentration of the drug to reach half of its original value.
Elimination rate constant
Time frame: 12 hours
The rate at which a drug is removed from the body.
Area under the curve
Time frame: 12 hours
The integral of the concentration-time curve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- 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.
Nermeen Ashoush, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trelagliptin in people with Diabetes Mellitus, run by British University In Egypt at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 5 May 2020. 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 Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bassam Ayoub, PhD (26890000 ext. 184, bassam.ayoub@bue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 12 hours). 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 5 May 2020.