Trial Outcomes & Findings for A Phase 1 Absolute Bioavailability Study For Oral Crizotinib In Healthy Volunteers (NCT NCT01168934)

NCT ID: NCT01168934

Last Updated: 2011-10-24

Results Overview

AUC \[0 - ∞\]\[dn\] = Dose normalized area under the plasma concentration versus time curve (AUC\[dn\]) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - ∞) divided by dose.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 14 participants
• Primary outcome timeframe: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hours (hrs) post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B
• Results posted on: 2011-10-24

Participant Flow

Participant milestones

Measure	Crizotinib 50 mg IV First, Then Crizotinib 250 mg Oral Single intravenous (IV) dose of crizotinib 50 milligram (mg) in first intervention period; and single oral dose of crizotinib 250 mg immediate release tablet (IRT) in second intervention period. A washout period of at least 14 days was maintained between each period.	Crizotinib 250 mg Oral First, Then Crizotinib 50 mg IV Single oral dose of crizotinib 250 mg IRT in first intervention period; and single IV dose of crizotinib 50 mg in second intervention period. A washout period of at least 14 days was maintained between each period.
First Intervention Period STARTED	7	7
First Intervention Period COMPLETED	7	7
First Intervention Period NOT COMPLETED	0	0
Washout Period (at Least 14 Days) STARTED	7	7
Washout Period (at Least 14 Days) COMPLETED	7	7
Washout Period (at Least 14 Days) NOT COMPLETED	0	0
Second Intervention Period STARTED	7	7
Second Intervention Period COMPLETED	7	7
Second Intervention Period NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 1 Absolute Bioavailability Study For Oral Crizotinib In Healthy Volunteers

Baseline characteristics by cohort

Measure	Entire Study Population n=14 Participants Includes participants randomized to receive crizotinib 50 mg IV first and crizotinib 250 mg oral first.
Age Continuous	35.7 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hours (hrs) post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B

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 - ∞][dn] = Dose normalized area under the plasma concentration versus time curve (AUC[dn]) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - ∞) divided by dose.

Outcome measures

Measure	Crizotinib 50 mg IV n=14 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral n=14 Participants Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞][dn])	21.36 ng*hr/mL/mg Standard Deviation 3.99	9.28 ng*hr/mL/mg Standard Deviation 3.32

PRIMARY outcome

Timeframe: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B

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.

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	Crizotinib 50 mg IV n=14 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral n=14 Participants Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])	1067.00 ng*hr/mL Standard Deviation 198.54	2321.00 ng*hr/mL Standard Deviation 833.14

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B

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 zero (pre-dose) to the last measured concentration (AUClast).

Outcome measures

Measure	Crizotinib 50 mg IV n=14 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral n=14 Participants Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	1007.00 ng*hr/mL Standard Deviation 182.84	2250.00 ng*hr/mL Standard Deviation 821.30

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B

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

AUClast[dn] = Dose normalized area under the plasma concentration time-curve (AUC[dn]) from zero to the last measured concentration.

Outcome measures

Measure	Crizotinib 50 mg IV n=14 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral n=14 Participants Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn])	20.14 ng*hr/mL/mg Standard Deviation 3.63	9.00 ng*hr/mL/mg Standard Deviation 3.28

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B

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	Crizotinib 50 mg IV n=14 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral n=14 Participants Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Maximum Observed Plasma Concentration (Cmax)	155.00 ng/mL Standard Deviation 29.57	99.60 ng/mL Standard Deviation 28.82

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B

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	Crizotinib 50 mg IV n=14 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Time to Reach Maximum Observed Plasma Concentration (Tmax)	5.0 hr Interval 4.0 to 6.0	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B

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	Crizotinib 50 mg IV n=14 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral n=14 Participants Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Plasma Decay Half Life (t1/2)	38.86 hr Standard Deviation 6.10	28.98 hr Standard Deviation 2.96

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B

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.

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	Crizotinib 50 mg IV n=14 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Apparent Oral Clearance (CL/F)	107.7 L/hr Standard Deviation 36.1	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A

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.

CL is a quantitative measure of the rate at which a drug substance is removed from the body.

Outcome measures

Measure	Crizotinib 50 mg IV n=14 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Systemic Clearance (CL)	46.83 L/hr Standard Deviation 8.64	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B

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.

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 plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

Outcome measures

Measure	Crizotinib 50 mg IV n=14 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Apparent Volume of Distribution (Vz/F)	4478.0 L Standard Deviation 1665.3	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A

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.

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. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

Outcome measures

Measure	Crizotinib 50 mg IV n=14 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Volume of Distribution at Steady State (Vss)	1772.00 L Standard Deviation 328.75	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B

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 zero (pre-dose) to the last measured concentration (AUClast) of crizotinib metabolite (PF-06260182).

Outcome measures

Measure	Crizotinib 50 mg IV n=14 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral n=14 Participants Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)	35.61 ng*hr/mL Standard Deviation 17.64	342.70 ng*hr/mL Standard Deviation 116.22

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B

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. Here, the 'N = 13' is signifying those participants who were evaluable for this measure at the specified time point for this arm group.

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 - ∞) of crizotinib metabolite (PF-06260182).

Outcome measures

Measure	Crizotinib 50 mg IV n=13 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) for Crizotinib Metabolite (PF-06260182)	360.4 ng*hr/mL Standard Deviation 117.2	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B

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	Crizotinib 50 mg IV n=14 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral n=14 Participants Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)	3.01 ng/mL Standard Deviation 1.46	26.46 ng/mL Standard Deviation 6.41

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B

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	Crizotinib 50 mg IV n=14 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)	5.00 hr Interval 5.0 to 6.07	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B

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.

Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (MRAUClast).

Outcome measures

Measure	Crizotinib 50 mg IV n=14 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral n=14 Participants Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration for Crizotinib Metabolite Ratio (MRAUClast)	0.034 Ratio Standard Deviation 0.011	0.148 Ratio Standard Deviation 0.021

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B

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. Here, the 'N = 13' is signifying those participants who were evaluable for this measure at the specified time point for this arm group.

Molar ratio of metabolite to parent area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞) (MRAUC [0-∞]).

Outcome measures

Measure	Crizotinib 50 mg IV n=13 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Metabolite to Parent Ratio Area Under the Curve From Time Zero to Extrapolated Infinite Time (MRAUC [0-∞])	0.144 Ratio Standard Deviation 0.019	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B

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.

Metabolite to parent molar ratio of maximum observed plasma concentration (MRCmax).

Outcome measures

Measure	Crizotinib 50 mg IV n=14 Participants Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral n=14 Participants Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Metabolite to Parent Ratio Maximum Observed Plasma Concentration (MRCmax)	0.019 Ratio Standard Deviation 0.007	0.258 Ratio Standard Deviation 0.043

Adverse Events

Crizotinib 50 mg IV

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Crizotinib 250 mg Oral

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Crizotinib 50 mg IV n=14 participants at risk Single IV dose of crizotinib 50 mg (Treatment A \[Reference\]) in either intervention period.	Crizotinib 250 mg Oral n=14 participants at risk Single oral dose of crizotinib 250 mg (Treatment B \[Test\]) in either intervention period.
Gastrointestinal disorders Diarrhoea	14.3% 2/14 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.	28.6% 4/14 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 Flatulence	7.1% 1/14 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.	7.1% 1/14 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 Catheter site pain	14.3% 2/14 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% 0/14 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 Catheter site phlebitis	7.1% 1/14 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% 0/14 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 Influenza like illness	7.1% 1/14 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% 0/14 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 Back pain	7.1% 1/14 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% 0/14 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 Paraesthesia	7.1% 1/14 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.	7.1% 1/14 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	7.1% 1/14 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.	7.1% 1/14 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 Rhinorrhoea	7.1% 1/14 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.	7.1% 1/14 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

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Phone: 1-800-718-1021

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Results disclosure agreements

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