Eletriptan Pharmacokinetics In Korean Males

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01139515
Collaborator
(none)
16
1
4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Eletriptan commercial tablet
  • Drug: Eletriptan commercial tablet
  • Drug: Eletriptan commercial tablet
  • Drug: Eletriptan commercial tablet
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Study Start Date :
Jul 1, 2010
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment A

1 X 20 mg eletriptan

Drug: Eletriptan commercial tablet
20 mg tablet, single dose

Experimental: Treatment B

1 X 40 mg eletriptan

Drug: Eletriptan commercial tablet
40 mg tablet, single dose of 1 X 40 mg

Experimental: Treatment C

2 X 40 mg eletriptan

Drug: Eletriptan commercial tablet
40 mg tablet, single dose of 2 X 40 mg

Experimental: Treatment D

1 X 40 mg tablet given 2 hr after initial 1 X 40 mg tablet dose

Drug: Eletriptan commercial tablet
40 mg tablet, 1 X 40 mg given two times: the second 2 hours after the first

Outcome Measures

Primary Outcome Measures

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] [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-∞).

  2. AUC From Time Zero to Last Quantifiable Concentration (AUClast) [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).

  3. Maximum Observed Plasma Concentration (Cmax) [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 Outcome Measures

  1. Time to Reach Maximum Observed Plasma Concentration (Tmax) [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. Plasma Decay Half Life (t1/2) [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 is the time measured for the plasma concentration to decrease by one half.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • healthy male subjects, 18-55 years old

  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

  • provide informed consent

Exclusion Criteria:
  • blood pressure >140/90 mm Hg

  • any condition possibly affecting drug absorption

  • positive urine drug screen

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Seoul Korea, Republic of 110-744

Sponsors and Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01139515
Other Study ID Numbers:
  • A1601126
First Posted:
Jun 8, 2010
Last Update Posted:
Jan 28, 2021
Last Verified:
Jan 1, 2021
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg
Arm/Group Description 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. 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. 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. 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.
Period Title: First Intervention Period
STARTED 4 4 4 4
COMPLETED 4 4 4 4
NOT COMPLETED 0 0 0 0
Period Title: First Intervention Period
STARTED 4 4 4 4
COMPLETED 4 4 4 4
NOT COMPLETED 0 0 0 0
Period Title: First Intervention Period
STARTED 4 4 4 4
COMPLETED 4 4 4 4
NOT COMPLETED 0 0 0 0
Period Title: First Intervention Period
STARTED 4 4 4 4
COMPLETED 4 4 4 4
NOT COMPLETED 0 0 0 0
Period Title: First Intervention Period
STARTED 4 4 4 4
COMPLETED 4 4 4 4
NOT COMPLETED 0 0 0 0
Period Title: First Intervention Period
STARTED 4 4 4 4
COMPLETED 4 4 4 4
NOT COMPLETED 0 0 0 0
Period Title: First Intervention Period
STARTED 4 4 4 4
COMPLETED 4 4 4 4
NOT COMPLETED 0 0 0 0

Baseline Characteristics

Arm/Group Title Entire Study Population
Arm/Group Description 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).
Overall Participants 16
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
24.8
(2.9)
Sex: Female, Male (Count of Participants)
Female
0
0%
Male
16
100%

Outcome Measures

1. Primary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
Description 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-∞).
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)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title Eletriptan 20 mg Tablet Eletriptan 40 mg Tablet Eletriptan 80 mg Tablet Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose
Arm/Group Description Single oral dose of eletriptan 20 mg tablet (Treatment A). Single oral dose of eletriptan 40 mg tablet (Treatment B). Single oral dose of two eletriptan 40 mg tablets (Treatment C). Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
Measure Participants 16 16 16 16
Geometric Mean (Full Range) [ng* hr/mL]
291.3
575.6
1282.0
1278.0
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eletriptan 20 mg Tablet, Eletriptan 40 mg Tablet
Comments Natural log transformed, dose-normalized AUC[0- ∞] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Adjusted ratio of geometric means
Estimated Value 98.70
Confidence Interval (2-Sided) 90%
92.17 to 105.70
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Eletriptan 20 mg Tablet, Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose
Comments Natural log transformed, dose-normalized AUC[0- ∞] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Adjusted ratio of geometric means
Estimated Value 109.48
Confidence Interval (2-Sided) 90%
102.23 to 117.24
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Eletriptan 20 mg Tablet, Eletriptan 80 mg Tablet
Comments Natural log transformed, dose-normalized AUC[0- ∞] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Adjusted ratio of geometric means
Estimated Value 109.93
Confidence Interval (2-Sided) 90%
102.65 to 117.72
Parameter Dispersion Type:
Value:
Estimation Comments
2. Primary Outcome
Title AUC From Time Zero to Last Quantifiable Concentration (AUClast)
Description Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable 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)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title Eletriptan 20 mg Tablet Eletriptan 40 mg Tablet Eletriptan 80 mg Tablet Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose
Arm/Group Description Single oral dose of eletriptan 20 mg tablet (Treatment A). Single oral dose of eletriptan 40 mg tablet (Treatment B). Single oral dose of two eletriptan 40 mg tablets (Treatment C). Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
Measure Participants 16 16 16 16
Geometric Mean (Full Range) [ng*hr/mL]
281.2
558.7
1243.0
1244.0
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eletriptan 20 mg Tablet, Eletriptan 40 mg Tablet
Comments Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Adjusted geometric means ratio
Estimated Value 99.41
Confidence Interval (2-Sided) 90%
92.97 to 106.31
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Eletriptan 20 mg Tablet, Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose
Comments Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Adjusted ratio of geometric means
Estimated Value 110.52
Confidence Interval (2-Sided) 90%
103.36 to 118.18
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Eletriptan 20 mg Tablet, Eletriptan 80 mg Tablet
Comments Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Adjusted ratio of geometric means
Estimated Value 110.44
Confidence Interval (2-Sided) 90%
103.28 to 118.09
Parameter Dispersion Type:
Value:
Estimation Comments
3. Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Description
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)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title Eletriptan 20 mg Tablet Eletriptan 40 mg Tablet Eletriptan 80 mg Tablet Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose
Arm/Group Description Single oral dose of eletriptan 20 mg tablet (Treatment A). Single oral dose of eletriptan 40 mg tablet (Treatment B). Single oral dose of two eletriptan 40 mg tablets (Treatment C). Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
Measure Participants 16 16 16 16
Geometric Mean (Full Range) [ng/mL]
46.50
94.72
200.10
183.60
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eletriptan 20 mg Tablet, Eletriptan 40 mg Tablet
Comments Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Adjusted geometric means ratio
Estimated Value 101.81
Confidence Interval (2-Sided) 90%
85.97 to 120.58
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Eletriptan 20 mg Tablet, Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose
Comments Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Adjusted ratio of geometric means
Estimated Value 98.57
Confidence Interval (2-Sided) 90%
83.23 to 116.73
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Eletriptan 20 mg Tablet, Eletriptan 80 mg Tablet
Comments Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Adjusted ratio of geometric means
Estimated Value 107.44
Confidence Interval (2-Sided) 90%
90.72 to 127.25
Parameter Dispersion Type:
Value:
Estimation Comments
4. Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Description
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)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title Eletriptan 20 mg Tablet Eletriptan 40 mg Tablet Eletriptan 80 mg Tablet Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose
Arm/Group Description Single oral dose of eletriptan 20 mg tablet (Treatment A). Single oral dose of eletriptan 40 mg tablet (Treatment B). Single oral dose of two eletriptan 40 mg tablets (Treatment C). Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
Measure Participants 16 16 16 16
Median (Full Range) [Hr]
0.750
0.750
0.750
5.000
5. Secondary Outcome
Title Plasma Decay Half Life (t1/2)
Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title Eletriptan 20 mg Tablet Eletriptan 40 mg Tablet Eletriptan 80 mg Tablet Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose
Arm/Group Description Single oral dose of eletriptan 20 mg tablet (Treatment A). Single oral dose of eletriptan 40 mg tablet (Treatment B). Single oral dose of two eletriptan 40 mg tablets (Treatment C). Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
Measure Participants 16 16 16 16
Mean (Standard Deviation) [Hr]
4.924
(0.685)
4.630
(0.447)
4.576
(0.531)
4.753
(0.623)

Adverse Events

Time Frame
Adverse Event Reporting Description 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.
Arm/Group Title Eletriptan 20 mg Tablet Eletriptan 40 mg Tablet Eletriptan 80 mg Tablet Eletriptan 40 mg 2 Hrs Apart Repeated Dose
Arm/Group Description Single oral dose of eletriptan 20 mg tablet (Treatment A). Single oral dose of eletriptan 40 mg tablet (Treatment B). Single oral dose of two eletriptan 40 mg tablets (Treatment C). Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
All Cause Mortality
Eletriptan 20 mg Tablet Eletriptan 40 mg Tablet Eletriptan 80 mg Tablet Eletriptan 40 mg 2 Hrs Apart Repeated Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Eletriptan 20 mg Tablet Eletriptan 40 mg Tablet Eletriptan 80 mg Tablet Eletriptan 40 mg 2 Hrs Apart Repeated Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/16 (0%) 0/16 (0%) 0/16 (0%) 0/16 (0%)
Other (Not Including Serious) Adverse Events
Eletriptan 20 mg Tablet Eletriptan 40 mg Tablet Eletriptan 80 mg Tablet Eletriptan 40 mg 2 Hrs Apart Repeated Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/16 (6.3%) 1/16 (6.3%) 4/16 (25%) 3/16 (18.8%)
Gastrointestinal disorders
Nausea 1/16 (6.3%) 1/16 (6.3%) 1/16 (6.3%) 0/16 (0%)
Oral mucosa erosion 0/16 (0%) 0/16 (0%) 1/16 (6.3%) 1/16 (6.3%)
General disorders
Chest discomfort 0/16 (0%) 0/16 (0%) 1/16 (6.3%) 1/16 (6.3%)
Fatigue 0/16 (0%) 0/16 (0%) 1/16 (6.3%) 0/16 (0%)
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness 0/16 (0%) 0/16 (0%) 0/16 (0%) 1/16 (6.3%)
Nervous system disorders
Headache 0/16 (0%) 0/16 (0%) 2/16 (12.5%) 1/16 (6.3%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort 0/16 (0%) 0/16 (0%) 1/16 (6.3%) 1/16 (6.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.

Results Point of Contact

Name/Title Pfizer ClinicalTrials.gov Call Center
Organization Pfizer, Inc.
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01139515
Other Study ID Numbers:
  • A1601126
First Posted:
Jun 8, 2010
Last Update Posted:
Jan 28, 2021
Last Verified:
Jan 1, 2021