Trial Outcomes & Findings for Radiolabeled [14C]PF-02341066 Study To Investigate The Absorption, Metabolism And Excretion In Healthy Male Volunteers (NCT NCT01082380)

NCT ID: NCT01082380

Last Updated: 2012-02-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 6 participants
• Primary outcome timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours (hrs), 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose
• Results posted on: 2012-02-29

Participant Flow

Participant milestones

Measure	PF-02341066 250 mg Single oral dose of PF-02341066 250 milligram (mg) containing 100 micro-curie (μCi) Carbon -14\[14C\].
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiolabeled [14C]PF-02341066 Study To Investigate The Absorption, Metabolism And Excretion In Healthy Male Volunteers

Baseline characteristics by cohort

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Age Continuous	43.2 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours (hrs), 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: The Pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Maximum Observed Plasma Concentration (Cmax)	109.400 ng/mL Standard Deviation 54.153

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Time to Reach Maximum Observed Plasma Concentration (Tmax)	2.99 hr Interval 1.98 to 6.0

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.

Area under the concentration time-curve from zero to the last measured plasma concentration (AUClast).

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Area Under the Curve From Time Zero to Last Quantifiable Plasma Concentration (AUClast)	2686.0 ng*hr/mL Standard Deviation 1119.6

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.

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	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Area Under the Plasma Concentration Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]	2777.0 ng*hr/mL Standard Deviation 1114.9

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.

Plasma Decay half-life is the time measured for the concentration to decrease by one half.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Plasma Decay Half Life (t1/2)	93.970 hr Standard Deviation 13.797

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.

Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Apparent Oral Clearance (CL/F) of Plasma PF-02341066	90.140 L/hr Standard Deviation 23.984

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Apparent Volume of Distribution (V/F) in Plasma	12110.0 L Standard Deviation 4544.5

PRIMARY outcome

Timeframe: Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose

Population: The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.

CLr is the volume of plasma from which a substance is completely removed by the kidney in a given amount of time.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Renal Clearance (CLr) of PF-02341066	2.11 L/hr Standard Deviation 0.29

PRIMARY outcome

Timeframe: Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose

Population: The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.

Ae = concentration of unchanged drug excreted in the urine multiplied by volume of unchanged drug excreted in urine.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to Infinite Time (Ae)	5.847 mg Standard Deviation 3.450

PRIMARY outcome

Timeframe: Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose

Population: The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Total Amount of Unchanged Drug Excreted in the Urine Expressed as Percent of Dose From Time Zero to Infinite Time [Ae(%)]	2.339 Percent dose of unchanged drug Standard Deviation 1.380

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.

Radioactivity corresponds to 100 μCi [14C]PF-02341066.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Maximum Observed Concentration in Plasma Radioactivity (Cmax)	435.600 nanogram-equivalent/milliliter(ng-eq/mL) Standard Deviation 82.072

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.

Radioactivity corresponds to 100 μCi [14C]PF-02341066.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Time to Reach Maximum Observed Plasma Radioactivity Concentration (Tmax)	5.00 hr Interval 2.98 to 6.0

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.

Area under the concentration time-curve from zero to the last measured plasma concentration. Radioactivity corresponds to 100 μCi [14C]PF-02341066.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Area Under the Curve From Time Zero to Last Quantifiable Plasma Radioactivity Concentration (AUClast)	22830.0 ng-eq*hr/mL Standard Deviation 2636.4

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: Data was insufficient to analyze as only 2 participants were evaluable for the parameter.

Area under the concentration curve from time zero to extrapolated infinite time [AUC (0 - ∞)] in plasma. Radioactivity corresponds to 100 μCi [14C]PF-02341066.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: Data was insufficient to analyze as only 2 participants were evaluable for the parameter.

Plasma decay half-life is the time measured for the plasma radioactivity concentration to decrease by one half. Radioactivity corresponds to 100 μCi [14C]PF-02341066.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: Data was insufficient to analyze as only 2 participants were evaluable for the parameter.

Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: Data was insufficient to analyze as only 2 participants were evaluable for the parameter.

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.

Radioactivity corresponds to 100 μCi [14C]PF-02341066.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Maximum Observed Concentration of Radioactivity in Whole Blood (Cmax)	312.300 ng-eq/mL Standard Deviation 62.669

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.

Time to Reach Maximum Observed Concentration (Tmax) of Radioactivity in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Time to Reach Maximum Observed Concentration (Tmax) of Radioactivity in Whole Blood	4.00 hr Interval 2.98 to 6.0

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.

Area under the concentration time-curve from zero to the last measured concentration (AUClast) in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Radioactivity in Whole Blood	7032.0 ng-eq*hr/mL Standard Deviation 1284.2

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: Data was insufficient to analyze as only 2 participants were evaluable for the parameter.

Area under the concentration curve from time zero to extrapolated infinite time [AUC (0 - ∞)] in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: Data was insufficient to analyze as only 2 participants were evaluable for the parameter.

Decay half life (t1/2) is the time measured for the concentration to decrease by one half in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: Data was insufficient to analyze as only 2 participants were evaluable for the parameter.

Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: Data was insufficient to analyze as only 2 participants were evaluable for the parameter.

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose

Population: The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.

Cumulative amount excreted in urine at specified intervals after administration of a single 250-mg (100 μCi) oral dose of [14C]PF-02341066.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Total [14C] Data in Urine	56200000 ng-eq Standard Deviation 11500000

PRIMARY outcome

Timeframe: From Day 0 through pre-dose (Day1) and as passed through until up to 480 hrs post-dose

Population: The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.

Cumulative amount excreted in feces at specified intervals after administration of a single 250-mg (100 μCi) oral dose of [14C]PF-02341066.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Total [14C] Data in Feces	160000000 ng-eq Standard Deviation 15000000

PRIMARY outcome

Timeframe: Pre-dose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose for urine and Day 0 through pre-dose (Day1) and as passed through until up to 480 hrs post-dose for feces

Population: The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.

Overall cumulative percent of radioactive dose recovered in urine, feces and toilet tissue at specified intervals after administration of a single 250-mg (100 μCi) oral dose of [14C]PF-02341066.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Overall Cumulative Percent Recovery of Radioactivity Urine	22.20 Percent recovery of radioactivity Standard Deviation 4.63
Overall Cumulative Percent Recovery of Radioactivity Feces	63.10 Percent recovery of radioactivity Standard Deviation 5.93
Overall Cumulative Percent Recovery of Radioactivity Overall	85.20 Percent recovery of radioactivity Standard Deviation 8.38

PRIMARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose

Population: The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.

Identification was done by Radio-High Performance liquid chromatography (HPLC) chromatogram. Relative abundance (profiling) of metabolites in chromatogram were determined by dividing sum of radioactive content of fractions contributing to particular peak by sum of radioactive content of all fractions constructing the radio chromatogram. Metabolites accounting for an average of greater than or equal to (>=) 10% of total recoverable radioactivity in plasma were summarized. Radioactivity corresponds to 100 μCi [14C] PF-02341066.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Identification and Profiling of Metabolites of [14C]PF-02341066 in Plasma PF-02341066	33.1 Percentage of recovered radioactivity
Identification and Profiling of Metabolites of [14C]PF-02341066 in Plasma M10, PF-06260182	10.2 Percentage of recovered radioactivity

PRIMARY outcome

Timeframe: From Day 0 through pre-dose (Day1) and as passed through until up to 480 hrs post-dose

Population: The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.

In feces, metabolite abundance (profiling) was calculated by multiplying the fractional contribution of radioactive response for the peak in the Radio-HPLC chromatogram to the total radioactivity detected by the percent of administered dose recovered in the matrix. Only those metabolites that were a component of a chromatographic peak that accounted for an average of >=1% of the administered dose, were summarized. Radioactivity corresponds to 100 μCi [14C] PF-02341066.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Identification and Profiling of Metabolites of [14C]PF-02341066 in Feces PF-02341066	53.5 Percentage of radioactive dose
Identification and Profiling of Metabolites of [14C]PF-02341066 in Feces M8	NA Percentage of radioactive dose Data was collected but could not be quantified.

PRIMARY outcome

Timeframe: Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose

Population: The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.

In urine, metabolite abundance (profiling) was calculated by multiplying the fractional contribution of radioactive response for the peak in the Radio-HPLC chromatogram to the total radioactivity detected by the percent of administered dose recovered in the matrix. Only those metabolites that were a component of a chromatographic peak that accounted for an average of >=1% of the administered dose, were summarized. Radioactivity corresponds to 100 μCi [14C] PF-02341066.

Outcome measures

Measure	PF-02341066 250 mg n=6 Participants Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Identification and Profiling of Metabolites of [14C]PF-02341066 in Urine PF-02341066	2.4 Percentage of radioactive dose
Identification and Profiling of Metabolites of [14C]PF-02341066 in Urine M8	4.5 Percentage of radioactive dose

Adverse Events

PF-02341066 250 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PF-02341066 250 mg n=6 participants at risk Single oral dose of PF-02341066 250 mg containing 100 μCi \[14C\].
Gastrointestinal disorders Abdominal discomfort	16.7% 1/6 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 Abdominal pain upper	16.7% 1/6 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 Constipation	16.7% 1/6 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 Diarrhoea	66.7% 4/6 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 Dyspepsia	16.7% 1/6 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 Somnolence	16.7% 1/6 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.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	16.7% 1/6 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.
Skin and subcutaneous tissue disorders Skin exfoliation	16.7% 1/6 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

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place