HealthyPhase 1NCT01139515

Eletriptan Pharmacokinetics In Korean Males

A Phase 1 study testing Eletriptan commercial tablet in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in South Korea.

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

The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK) characteristics to those seen in other populations. 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
What is being tested?: Eletriptan commercial tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteSouth Korea
Study dates: Jul 2010to Jul 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

healthy male subjects, 18-55 years old
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
provide informed consent

Who cannot join

blood pressure >140/90 mm Hg
any condition possibly affecting drug absorption
positive urine drug screen

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Pfizer Investigational Site
Seoul, 110-744

Other trials in South Korea

About this study

Official title: An Open Label, Single And Repeat Dose Randomized Crossover Study To Estimate The Pharmacokinetics And Safety Of Eletriptan Hydrobromide Tablets In Healthy Korean Male Subjects

The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK) characteristics to those seen in other populations.

Conditions: Healthy
Being tested: Eletriptan commercial tablet
Keywords: pharmacokinetic, eletriptan, Korean, crossover

What participants receive

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

Eletriptan commercial tabletDrug
20 mg tablet, single dose
Eletriptan commercial tabletDrug
40 mg tablet, single dose of 1 X 40 mg
Eletriptan commercial tabletDrug
40 mg tablet, single dose of 2 X 40 mg
Eletriptan commercial tabletDrug
40 mg tablet, 1 X 40 mg given two times: the second 2 hours after the first

Study groups in NCT01139515
Study group	Role	What they receive
Treatment A	Experimental	1 X 20 mg eletriptan Receives: Drug: Eletriptan commercial tablet
Treatment B	Experimental	1 X 40 mg eletriptan Receives: Drug: Eletriptan commercial tablet
Treatment C	Experimental	2 X 40 mg eletriptan Receives: Drug: Eletriptan commercial tablet
Treatment D	Experimental	1 X 40 mg tablet given 2 hr after initial 1 X 40 mg tablet dose Receives: Drug: Eletriptan commercial tablet

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-∞)]
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
Measured: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose(D)
AUC From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Measured: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)
Maximum Observed Plasma Concentration (Cmax)
Measured: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)

Secondary outcomes (2)

Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)
Plasma Decay Half Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)

Timeline

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

Jul 2010Jul 2010

First posted8 Jun 2010 (estimated)
Study startJul 2010
Primary completionJul 2010
Study completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies 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: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01139515
Sponsor's protocol ID: A1601126
Status last verified: Jan 2021
First submitted: 7 Jun 2010
Last updated: 28 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Single And Repeat Dose Randomized Crossover Study To Estimate The Pharmacokinetics And Safety Of Eletriptan Hydrobromide Tablets In Healthy Korean Male Subjects
ClinicalTrials.gov ID: NCT01139515
Acronym / sponsor ID: A1601126
Conditions: Healthy
Keywords: pharmacokinetic, eletriptan, Korean, crossover
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 8 Jun 2010 (estimated)
Results: Posted 12 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK) characteristics to those seen in other populations.

Study design

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

Arm	Type	Receives
Treatment A	Experimental	Drug: Eletriptan commercial tablet1 X 20 mg eletriptan
Treatment B	Experimental	Drug: Eletriptan commercial tablet1 X 40 mg eletriptan
Treatment C	Experimental	Drug: Eletriptan commercial tablet2 X 40 mg eletriptan
Treatment D	Experimental	Drug: Eletriptan commercial tablet1 X 40 mg tablet given 2 hr after initial 1 X 40 mg tablet dose

Who may qualify

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

Key inclusion criteria (3 listed)

healthy male subjects, 18-55 years old
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
provide informed consent

Key exclusion criteria (3 listed)

blood pressure >140/90 mm Hg
any condition possibly affecting drug absorption
positive urine drug screen

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
Eletriptan commercial tablet20 mg tablet, single dose	Drug	Treatment A
Eletriptan commercial tablet40 mg tablet, single dose of 1 X 40 mg	Drug	Treatment B
Eletriptan commercial tablet40 mg tablet, single dose of 2 X 40 mg	Drug	Treatment C
Eletriptan commercial tablet40 mg tablet, 1 X 40 mg given two times: the second 2 hours after the first	Drug	Treatment D

Primary outcome

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
Time frame: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose(D)
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
AUC From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)
Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)

2 secondary outcomes

Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)
Plasma Decay Half Life (t1/2)
Time frame: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)

Results and safety

Results posted to the registry on 12 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose	4	4
Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose	4	4
Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg	4	4
Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg	4	4

Primary outcome: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]

Time frame: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose(D). Geometric mean (Full Range). Unit: ng* hr/mL

Measure	Eletriptan 20 mg Tablet n = 16	Eletriptan 40 mg Tablet n = 16	Eletriptan 80 mg Tablet n = 16	Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose n = 16
Value	291.3 (185.0 to 690.0)	575.6 (358.0 to 1230.0)	1282.0 (806.0 to 2140.0)	1278.0 (842.0 to 2310.0)

Eletriptan 20 mg Tablet vs Eletriptan 40 mg Tablet: Adjusted ratio of geometric means: 98.70 (90% CI 92.17 to 105.70)
Eletriptan 20 mg Tablet vs Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose: Adjusted ratio of geometric means: 109.48 (90% CI 102.23 to 117.24)
Eletriptan 20 mg Tablet vs Eletriptan 80 mg Tablet: Adjusted ratio of geometric means: 109.93 (90% CI 102.65 to 117.72)

Population analysed: Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Primary outcome: AUC From Time Zero to Last Quantifiable Concentration (AUClast)

Measure	Eletriptan 20 mg Tablet n = 16	Eletriptan 40 mg Tablet n = 16	Eletriptan 80 mg Tablet n = 16	Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose n = 16
Value	281.2 (180.0 to 646.0)	558.7 (351.0 to 1160.0)	1243.0 (767.0 to 2080.0)	1244.0 (808.0 to 2210.0)

Eletriptan 20 mg Tablet vs Eletriptan 40 mg Tablet: Adjusted geometric means ratio: 99.41 (90% CI 92.97 to 106.31)
Eletriptan 20 mg Tablet vs Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose: Adjusted ratio of geometric means: 110.52 (90% CI 103.36 to 118.18)
Eletriptan 20 mg Tablet vs Eletriptan 80 mg Tablet: Adjusted ratio of geometric means: 110.44 (90% CI 103.28 to 118.09)

Population analysed: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Measure	Eletriptan 20 mg Tablet n = 16	Eletriptan 40 mg Tablet n = 16	Eletriptan 80 mg Tablet n = 16	Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose n = 16
Value	46.50 (29.50 to 97.80)	94.72 (47.50 to 224.00)	200.10 (77.80 to 423.00)	183.60 (97.00 to 281.00)

Eletriptan 20 mg Tablet vs Eletriptan 40 mg Tablet: Adjusted geometric means ratio: 101.81 (90% CI 85.97 to 120.58)
Eletriptan 20 mg Tablet vs Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose: Adjusted ratio of geometric means: 98.57 (90% CI 83.23 to 116.73)
Eletriptan 20 mg Tablet vs Eletriptan 80 mg Tablet: Adjusted ratio of geometric means: 107.44 (90% CI 90.72 to 127.25)

Population analysed: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Eletriptan 20 mg Tablet	0 of 16 (0%)	1 of 16 (6.3%)	Not reported
Eletriptan 40 mg Tablet	0 of 16 (0%)	1 of 16 (6.3%)	Not reported
Eletriptan 80 mg Tablet	0 of 16 (0%)	4 of 16 (25%)	Not reported
Eletriptan 40 mg 2 Hrs Apart Repeated Dose	0 of 16 (0%)	3 of 16 (18.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

Pfizer CT.gov Call Center study director

Pfizer

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 Eletriptan commercial tablet in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in South Korea.

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 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: finished, as of the sponsor's last update on 28 Jan 2021. 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 South Korea. 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?

Yes. Results are posted in the registry (first posted 12 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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-∞)] (time frame: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose(D)). The study lists 3 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 NCT01139515.

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 Jan 2021.