Healthy VolunteersNCT04365907
Omarigliptin in Four Healthy Egyptian Volunteers
A study testing Zafatek tablets in people with Healthy Volunteers, run by British University In Egypt at 1 site in Egypt.
Trial summary
The proposed study will consider the LC-MS/MS quantitative determination of Omarigliptin after administration to four Egyptian volunteers. The main aim of the study is to confirm that the developed LC-MS/MS method is applicable for the bio-assay of the drug in the actual biological samples at the time of Cmax (nearly… Read more about this study
- Who is it for?
- Ages 23 to 37 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Zafatek tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Mar 2020to 28 May 2020
- Phase
- Interventional
- 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 23 to 37 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Must be able to swallow tablets
Who cannot join
- Insulin dependent diabetes
- Type-2 diabetes
- Hospitalized within 1 week
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
The British University in Egypt
Cairo, El-Sherouk, 11837
Bassam Ayoub, PhD, 01225104337, Bassam.ayoub@bue.edu.eg
Nermeen Ashoush, PhD, 01001809397, nermeen.ashoush@bue.edu.eg
About this study
Official title: Enhanced Extraction Technique of Omarigliptin From Human Plasma: Applied to Biological Samples From Healthy Human Volunteers
The proposed study will consider the LC-MS/MS quantitative determination of Omarigliptin after administration to four Egyptian volunteers. The main aim of the study is to confirm that the developed LC-MS/MS method is applicable for the bio-assay of the drug in the actual biological samples at the time of Cmax (nearly about 1.5 hours). The design of the study is open labeled, one treatment, one period, single dose study. The concentration of the drugs after 1.5 h will be determined 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 four 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 four, healthy, adult, male, smoking, Egyptian volunteers (age: 23-37 years, Average weight: 81.6 kg, Average BMI: 30.4) will be collected at 1.5 h, 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 Marizev® tablet nominally containing 12.5 mg of Omarigliptin (first arm as 4 volunteers). The blood samples (1 mL of each sample) will be centrifuged at 3000 rpm for 5 minutes, 100 µL of the plasma will be separated and spiked with the internal standard working solution and then the sample preparation and LC-MS/MS determination will be applied. Blood glucose level will be determined for all volunteers at different time intervals to monitor any hypoglycemic effect to ensure their safety all over the study. The study will be conducted as per FDA guidelines \& 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
- Healthy Volunteers
- Being tested
- Zafatek tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zafatek tabletsDrug
Once weekly new anti-diabetic drug approved only in Japan
| Study group | Role | What they receive |
|---|---|---|
| Omarigliptin 12.5 mg | Experimental | Drug: Omarigliptin 12.5 mg Once weekly new anti-diabetic drug approved only in Japan Other Name: Zafatek tablets Receives: Drug: Zafatek tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration (nMol/L) after 1.5 hours
Only one determination of human plasma concentration (nM/L) of omarigliptin will be determined after 1.5 hours for the current investigation.
Measured: 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start11 Mar 2020
- Primary completion20 May 2020 (estimated)
- Study completion28 May 2020 (estimated)
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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassam Mahfouz Ayoub, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365907
- Sponsor's protocol ID
- CDRD-3
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 28 Apr 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 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Extraction Technique of Omarigliptin From Human Plasma: Applied to Biological Samples From Healthy Human Volunteers
- ClinicalTrials.gov ID
- NCT04365907
- Acronym / sponsor ID
- CDRD-3
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 20 May 2020 (estimated)
- Study completion
- 28 May 2020 (estimated)
- First posted
- 28 Apr 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 LC-MS/MS quantitative determination of Omarigliptin after administration to four Egyptian volunteers. The main aim of the study is to confirm that the developed LC-MS/MS method is applicable for the bio-assay of the drug in the actual biological samples at the time of Cmax (nearly about 1.5 hours). The design of the study is open labeled, one treatment, one period, single dose study. The concentration of the drugs after 1.5 h will be determined 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 four 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 four, healthy, adult, male, smoking, Egyptian volunteers (age: 23-37 years, Average weight: 81.6 kg, Average BMI: 30.4) will be collected at 1.5 h, 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 Marizev® tablet nominally containing 12.5 mg of Omarigliptin (first arm as 4 volunteers). The blood samples (1 mL of each sample) will be centrifuged at 3000 rpm for 5 minutes, 100 µL of the plasma will be separated and spiked with the internal standard working solution and then the sample preparation and LC-MS/MS determination will be applied. Blood glucose level will be determined for all volunteers at different time intervals to monitor any hypoglycemic effect to ensure their safety all over the study. The study will be conducted as per FDA guidelines \& 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omarigliptin 12.5 mg | Experimental | Drug: Zafatek tabletsDrug: Omarigliptin 12.5 mg Once weekly new anti-diabetic drug approved only in Japan Other Name: Zafatek tablets |
Who may qualify
- Ages
- 23 to 37 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- Must be able to swallow tablets
Key exclusion criteria (3 listed)
- Insulin dependent diabetes
- Type-2 diabetes
- Hospitalized within 1 week
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 |
|---|---|---|
| Zafatek tabletsOnce weekly new anti-diabetic drug approved only in Japan | Drug | Omarigliptin 12.5 mg |
Primary outcome
Plasma concentration (nMol/L) after 1.5 hours
Time frame: 1.5 hours
Only one determination of human plasma concentration (nM/L) of omarigliptin will be determined after 1.5 hours for the current investigation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zafatek tablets in people with Healthy Volunteers, 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 2 inclusion and 3 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 28 Apr 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration (nMol/L) after 1.5 hours (time frame: 1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.