Trial Outcomes & Findings for Eletriptan Pharmacokinetics In Korean Males (NCT NCT01139515)
NCT ID: NCT01139515
Last Updated: 2021-01-28
Results Overview
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-∞).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
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 posted on
2021-01-28
Participant Flow
Participant milestones
| Measure |
Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose
Single oral dose of eletriptan 20 mg tablet in first intervention period; followed by single oral dose of eletriptan 40 mg tablet in second intervention period; then single oral dose of eletriptan 80 mg tablet in third intervention period; and two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in fourth intervention period. A washout period of 46 hrs was maintained between each period.
|
Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose
Single oral dose of eletriptan 40 mg tablet in first intervention period; followed by single oral dose of eletriptan 80 mg tablet in second intervention period; then single oral dose of eletriptan 20 mg tablet in third intervention period; and two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in fourth intervention period. A washout period of 46 hrs was maintained between each period.
|
Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg
Single oral dose of eletriptan 80 mg tablet in first intervention period; followed by two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in second intervention period; then single oral dose of eletriptan 40 mg tablet in third intervention period; and single oral dose of eletriptan 20 mg tablet in fourth intervention period. A washout period of 46 hrs was maintained between each period.
|
Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg
Two oral doses of 40 mg eletriptan tablet administered 2 hrs apart tablet in first intervention period; followed by single oral dose of eletriptan 20 mg in second intervention period; then single oral dose of eletriptan 80 mg tablet in third intervention period; and single oral dose of eletriptan 40 mg tablet in fourth intervention period. A washout period of 46 hrs was maintained between each period.
|
|---|---|---|---|---|
|
First Intervention Period
STARTED
|
4
|
4
|
4
|
4
|
|
First Intervention Period
COMPLETED
|
4
|
4
|
4
|
4
|
|
First Intervention Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period I (46hrs)
STARTED
|
4
|
4
|
4
|
4
|
|
Washout Period I (46hrs)
COMPLETED
|
4
|
4
|
4
|
4
|
|
Washout Period I (46hrs)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention Period
STARTED
|
4
|
4
|
4
|
4
|
|
Second Intervention Period
COMPLETED
|
4
|
4
|
4
|
4
|
|
Second Intervention Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (46 Hrs)
STARTED
|
4
|
4
|
4
|
4
|
|
Washout Period 2 (46 Hrs)
COMPLETED
|
4
|
4
|
4
|
4
|
|
Washout Period 2 (46 Hrs)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Third Intervention Period
STARTED
|
4
|
4
|
4
|
4
|
|
Third Intervention Period
COMPLETED
|
4
|
4
|
4
|
4
|
|
Third Intervention Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 3 (46 Hrs)
STARTED
|
4
|
4
|
4
|
4
|
|
Washout Period 3 (46 Hrs)
COMPLETED
|
4
|
4
|
4
|
4
|
|
Washout Period 3 (46 Hrs)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Fourth Intervention Period
STARTED
|
4
|
4
|
4
|
4
|
|
Fourth Intervention Period
COMPLETED
|
4
|
4
|
4
|
4
|
|
Fourth Intervention Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Eletriptan Pharmacokinetics In Korean Males
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=16 Participants
All participants randomized to any treatment (Eletriptan 20 mg tablet first, eletriptan 40 mg tablet first, eletriptan 80 mg tablet first, and eletriptan 40 mg 2 hrs apart repeated dose (80 mg in total).
|
|---|---|
|
Age, Continuous
|
24.8 Years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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-∞).
Outcome measures
| Measure |
Eletriptan 20 mg Tablet
n=16 Participants
Single oral dose of eletriptan 20 mg tablet (Treatment A).
|
Eletriptan 40 mg Tablet
n=16 Participants
Single oral dose of eletriptan 40 mg tablet (Treatment B).
|
Eletriptan 80 mg Tablet
n=16 Participants
Single oral dose of two eletriptan 40 mg tablets (Treatment C).
|
Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose
n=16 Participants
Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
|
291.3 ng* hr/mL
Interval 185.0 to 690.0
|
575.6 ng* hr/mL
Interval 358.0 to 1230.0
|
1282.0 ng* hr/mL
Interval 806.0 to 2140.0
|
1278.0 ng* hr/mL
Interval 842.0 to 2310.0
|
PRIMARY outcome
Timeframe: 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)Population: 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.
Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Outcome measures
| Measure |
Eletriptan 20 mg Tablet
n=16 Participants
Single oral dose of eletriptan 20 mg tablet (Treatment A).
|
Eletriptan 40 mg Tablet
n=16 Participants
Single oral dose of eletriptan 40 mg tablet (Treatment B).
|
Eletriptan 80 mg Tablet
n=16 Participants
Single oral dose of two eletriptan 40 mg tablets (Treatment C).
|
Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose
n=16 Participants
Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
|
|---|---|---|---|---|
|
AUC From Time Zero to Last Quantifiable Concentration (AUClast)
|
281.2 ng*hr/mL
Interval 180.0 to 646.0
|
558.7 ng*hr/mL
Interval 351.0 to 1160.0
|
1243.0 ng*hr/mL
Interval 767.0 to 2080.0
|
1244.0 ng*hr/mL
Interval 808.0 to 2210.0
|
PRIMARY outcome
Timeframe: 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)Population: 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.
Outcome measures
| Measure |
Eletriptan 20 mg Tablet
n=16 Participants
Single oral dose of eletriptan 20 mg tablet (Treatment A).
|
Eletriptan 40 mg Tablet
n=16 Participants
Single oral dose of eletriptan 40 mg tablet (Treatment B).
|
Eletriptan 80 mg Tablet
n=16 Participants
Single oral dose of two eletriptan 40 mg tablets (Treatment C).
|
Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose
n=16 Participants
Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
46.50 ng/mL
Interval 29.5 to 97.8
|
94.72 ng/mL
Interval 47.5 to 224.0
|
200.10 ng/mL
Interval 77.8 to 423.0
|
183.60 ng/mL
Interval 97.0 to 281.0
|
SECONDARY outcome
Timeframe: 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)Population: 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.
Outcome measures
| Measure |
Eletriptan 20 mg Tablet
n=16 Participants
Single oral dose of eletriptan 20 mg tablet (Treatment A).
|
Eletriptan 40 mg Tablet
n=16 Participants
Single oral dose of eletriptan 40 mg tablet (Treatment B).
|
Eletriptan 80 mg Tablet
n=16 Participants
Single oral dose of two eletriptan 40 mg tablets (Treatment C).
|
Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose
n=16 Participants
Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
0.750 Hr
Interval 0.5 to 2.0
|
0.750 Hr
Interval 0.5 to 4.0
|
0.750 Hr
Interval 0.5 to 6.0
|
5.000 Hr
Interval 0.75 to 5.02
|
SECONDARY outcome
Timeframe: 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)Population: 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.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Eletriptan 20 mg Tablet
n=16 Participants
Single oral dose of eletriptan 20 mg tablet (Treatment A).
|
Eletriptan 40 mg Tablet
n=16 Participants
Single oral dose of eletriptan 40 mg tablet (Treatment B).
|
Eletriptan 80 mg Tablet
n=16 Participants
Single oral dose of two eletriptan 40 mg tablets (Treatment C).
|
Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose
n=16 Participants
Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
|
|---|---|---|---|---|
|
Plasma Decay Half Life (t1/2)
|
4.924 Hr
Standard Deviation 0.685
|
4.630 Hr
Standard Deviation 0.447
|
4.576 Hr
Standard Deviation 0.531
|
4.753 Hr
Standard Deviation 0.623
|
Adverse Events
Eletriptan 20 mg Tablet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Eletriptan 40 mg Tablet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Eletriptan 80 mg Tablet
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Eletriptan 40 mg 2 Hrs Apart Repeated Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eletriptan 20 mg Tablet
n=16 participants at risk
Single oral dose of eletriptan 20 mg tablet (Treatment A).
|
Eletriptan 40 mg Tablet
n=16 participants at risk
Single oral dose of eletriptan 40 mg tablet (Treatment B).
|
Eletriptan 80 mg Tablet
n=16 participants at risk
Single oral dose of two eletriptan 40 mg tablets (Treatment C).
|
Eletriptan 40 mg 2 Hrs Apart Repeated Dose
n=16 participants at risk
Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Oral mucosa erosion
|
0.00%
0/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest discomfort
|
0.00%
0/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
2/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER