Trial Outcomes & Findings for Relative Drug Exposures Of Two Formulations of PF-02341066 (NCT NCT00939731)
NCT ID: NCT00939731
Last Updated: 2011-10-24
Results Overview
Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hours (hrs) post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2
Results posted on
2011-10-24
Participant Flow
Participant milestones
| Measure |
PF-02341066 250 mg IRT First, Then PF-02341066 250 mg PIC
Single oral dose of PF-02341066 250 mg immediate release tablet (IRT) in first intervention period; and single oral dose of PF-02341066 250 mg powder in capsule (PIC) in second intervention period. A washout period of at least 14 days was maintained between each period.
|
PF-02341066 250 mg PIC First, Then PF-02341066 250 mg IRT
Single oral dose of PF-02341066 250 mg PIC in first intervention period; and single oral dose of PF-02341066 250 mg IRT in second intervention period. A washout period of at least 14 days was maintained between each period.
|
|---|---|---|
|
First Intervention Period
STARTED
|
12
|
12
|
|
First Intervention Period
COMPLETED
|
12
|
12
|
|
First Intervention Period
NOT COMPLETED
|
0
|
0
|
|
Washout Period (at Least 14 Days)
STARTED
|
12
|
12
|
|
Washout Period (at Least 14 Days)
COMPLETED
|
12
|
12
|
|
Washout Period (at Least 14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention Period
STARTED
|
12
|
12
|
|
Second Intervention Period
COMPLETED
|
12
|
12
|
|
Second Intervention Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Relative Drug Exposures Of Two Formulations of PF-02341066
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=24 Participants
Includes participants randomized to receive PF-02341066 250 mg IRT first and PF-02341066 250 mg PIC first.
|
|---|---|
|
Age Continuous
|
32.1 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hours (hrs) post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2Population: 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.
Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).
Outcome measures
| Measure |
PF-02341066 250 mg PIC
n=24 Participants
Single oral dose of PF-02341066 250 mg PIC (Treatment A \[Reference\]) in either first intervention period or second intervention period.
|
PF-02341066 250 mg IRT
n=24 Participants
Single oral dose of PF-02341066 250 mg IRT (Treatment B \[Test\]) in either first intervention period or second intervention period.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
|
2804.5 ng*hr/mL
Standard Deviation 941.4
|
2597.3 ng*hr/mL
Standard Deviation 924.1
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2Population: 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 |
PF-02341066 250 mg PIC
n=24 Participants
Single oral dose of PF-02341066 250 mg PIC (Treatment A \[Reference\]) in either first intervention period or second intervention period.
|
PF-02341066 250 mg IRT
n=24 Participants
Single oral dose of PF-02341066 250 mg IRT (Treatment B \[Test\]) in either first intervention period or second intervention period.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])
|
2945.5 ng*hr/mL
Standard Deviation 955.2
|
2722.5 ng*hr/mL
Standard Deviation 939.2
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2Population: 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 |
PF-02341066 250 mg PIC
n=24 Participants
Single oral dose of PF-02341066 250 mg PIC (Treatment A \[Reference\]) in either first intervention period or second intervention period.
|
PF-02341066 250 mg IRT
n=24 Participants
Single oral dose of PF-02341066 250 mg IRT (Treatment B \[Test\]) in either first intervention period or second intervention period.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
113.35 ng/mL
Standard Deviation 34.22
|
112.11 ng/mL
Standard Deviation 34.87
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2Population: 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 |
PF-02341066 250 mg PIC
n=24 Participants
Single oral dose of PF-02341066 250 mg PIC (Treatment A \[Reference\]) in either first intervention period or second intervention period.
|
PF-02341066 250 mg IRT
n=24 Participants
Single oral dose of PF-02341066 250 mg IRT (Treatment B \[Test\]) in either first intervention period or second intervention period.
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
6.00 hr
Interval 2.0 to 8.0
|
6.00 hr
Interval 2.0 to 8.0
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2Population: 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 |
PF-02341066 250 mg PIC
n=24 Participants
Single oral dose of PF-02341066 250 mg PIC (Treatment A \[Reference\]) in either first intervention period or second intervention period.
|
PF-02341066 250 mg IRT
n=24 Participants
Single oral dose of PF-02341066 250 mg IRT (Treatment B \[Test\]) in either first intervention period or second intervention period.
|
|---|---|---|
|
Plasma Decay Half Life (t1/2)
|
29.48 hr
Standard Deviation 4.62
|
29.10 hr
Standard Deviation 4.66
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2Population: 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 |
PF-02341066 250 mg PIC
n=24 Participants
Single oral dose of PF-02341066 250 mg PIC (Treatment A \[Reference\]) in either first intervention period or second intervention period.
|
PF-02341066 250 mg IRT
n=24 Participants
Single oral dose of PF-02341066 250 mg IRT (Treatment B \[Test\]) in either first intervention period or second intervention period.
|
|---|---|---|
|
Apparent Oral Clearance (CL/F)
|
84.9 L/hr
Standard Deviation 31.6
|
91.8 L/hr
Standard Deviation 35.8
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2Population: 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. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
PF-02341066 250 mg PIC
n=24 Participants
Single oral dose of PF-02341066 250 mg PIC (Treatment A \[Reference\]) in either first intervention period or second intervention period.
|
PF-02341066 250 mg IRT
n=24 Participants
Single oral dose of PF-02341066 250 mg IRT (Treatment B \[Test\]) in either first intervention period or second intervention period.
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/F)
|
3566.8 L
Standard Deviation 1820.5
|
3809.3 L
Standard Deviation 1784.4
|
Adverse Events
PF-02341066 250 mg PIC
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-02341066 250 mg IRT
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-02341066 250 mg PIC
n=24 participants at risk
Single oral dose of PF-02341066 250 mg PIC (Treatment A \[Reference\]) in either first intervention period or second intervention period.
|
PF-02341066 250 mg IRT
n=24 participants at risk
Single oral dose of PF-02341066 250 mg IRT (Treatment B \[Test\]) in either first intervention period or second intervention period.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
12.5%
3/24
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.
|
16.7%
4/24
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
|
4.2%
1/24
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%
3/24
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
|
4.2%
1/24
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.
|
4.2%
1/24
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
|
4.2%
1/24
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.
|
4.2%
1/24
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 tenderness
|
4.2%
1/24
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%
0/24
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
|
4.2%
1/24
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%
0/24
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.
|
|
Injury, poisoning and procedural complications
Excoriation
|
4.2%
1/24
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%
0/24
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
Dizziness
|
0.00%
0/24
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.
|
4.2%
1/24
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
|
4.2%
1/24
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%
0/24
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
|
0.00%
0/24
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.
|
4.2%
1/24
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
- Publication restrictions are in place