Open Label Drug Interaction Study Evaluating Desvenlafaxi... | NCT01188668

ID	Type	Description	Link
3151A1-1207

Label	Type	Description	Intervention Names
Aripiprazole + Desvenlafaxine SR	Experimental		Drug: Aripiprazole Drug: Aripiprazole + desvenlafaxine succinate sustained release

Name	Type	Description	Arm Group Labels	Other Names
Aripiprazole	Drug	Period 1-Aripiprazole 5mg on study day 1.	Aripiprazole + Desvenlafaxine SR

Measure	Description	Time Frame
Aripiprazole Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR	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 - ∞); measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).	Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

Measure	Description	Time Frame
Aripiprazole Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR	Cmax measured as nanograms per milliliters (ng/mL).	Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Miami	Florida	33126	United States
Pfizer Investigational Site

ID	Title	Description
FG000	Aripiprazole 5 mg, Aripiprazole 5 mg + DVS SR 100 mg	Aripiprazole (ARIP) as a single oral dose of 5 milligrams (mg) Period 1 / Day 1. Desvenlafaxine sustained release (DVS SR) as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.

ID	Title	Description
BG000	Aripiprazole 5 mg, Aripiprazole 5 mg + DVS SR 100 mg	Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1. DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.

Units	Counts
Participants	BG00038

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Aripiprazole Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR

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 - ∞); measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).

Pharmacokinetic (PK) parameter analysis population: all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=Number of participants contributing to the mean.

Posted

Geometric Mean

Standard Deviation

ng*hr/mL

Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

ID	Title	Description
OG000	Aripiprazole 5 mg (Period 1)	Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
OG001	Aripiprazole 5 mg + DVS SR 100 mg (Period 2)	DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.

Units	Counts
Participants	OG00037 OG00135

Title

Denominators

Categories

Title	Measurements
	OG0001494± 699.98 OG0011604± 561.45

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)					ratio of adjusted means	105.97			2-Sided	90	101.39	110.76			Values have been back-transformed from the log scale.	No	Superiority or Other

Secondary

Aripiprazole Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR

Cmax measured as nanograms per milliliters (ng/mL).

PK parameter analysis population. N=Number of participants contributing to the mean.

Posted

Geometric Mean

Standard Deviation

ng/mL

ID	Title	Description
OG000	Aripiprazole 5 mg (Period 1)	Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
OG001	Aripiprazole 5 mg + DVS SR 100 mg (Period 2)	DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.

Units	Counts
Participants

Secondary

Aripiprazole Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR

Time for maximum observed plasma concentration.

PK parameter analysis population. N=Number of participants contributing to the median.

Posted

Median

Full Range

hours

ID	Title	Description
OG000	Aripiprazole 5 mg (Period 1)	Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
OG001	Aripiprazole 5 mg + DVS SR 100 mg (Period 2)	DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.

Units	Counts
Participants

Secondary

Aripiprazole Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR

Terminal half-life is the time measured for the plasma concentration to decrease by one half.

PK parameter analysis population. N=Number of participants contributing to the mean.

Posted

Mean

Standard Deviation

hours

ID	Title	Description
OG000	Aripiprazole 5 mg (Period 1)	Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
OG001	Aripiprazole 5 mg + DVS SR 100 mg (Period 2)	DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.

Units	Counts
Participants

Secondary

Aripiprazole Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR

Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).

PK parameter analysis population. N=Number of participants contributing to the mean.

Posted

Geometric Mean

Standard Deviation

mL/min

ID	Title	Description
OG000	Aripiprazole 5 mg (Period 1)	Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
OG001	Aripiprazole 5 mg + DVS SR 100 mg (Period 2)	DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.

Units	Counts
Participants

Secondary

Aripiprazole Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR

Calculated as Dose / (AUCinf * kel); where kel=terminal phase rate constant.

PK parameter analysis population. N=Number of participants contributing to the mean.

Posted

Geometric Mean

Standard Deviation

liters

ID	Title	Description
OG000	Aripiprazole 5 mg (Period 1)	Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
OG001	Aripiprazole 5 mg + DVS SR 100 mg (Period 2)	DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.

Units	Counts
Participants

Secondary

Dehydro-aripiprazole (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR

Dehydro-aripiprazole is a metabolite of Aripiprazole. 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 - ∞).

PK parameter analysis population. N=Number of participants contributing to the mean.

Posted

Geometric Mean

Standard Deviation

ng*hr/mL

ID	Title	Description
OG000	Aripiprazole 5 mg (Period 1)	Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
OG001	Aripiprazole 5 mg + DVS SR 100 mg (Period 2)	DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.

Units

Secondary

Dehydro-aripiprazole (Metabolite) Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR

PK parameter analysis population. N=number of participants contributing to the mean.

Posted

Geometric Mean

Standard Deviation

ng/mL

Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing

ID	Title	Description
OG000	Aripiprazole 5 mg (Period 1)	Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
OG001	Aripiprazole 5 mg + DVS SR 100 mg (Period 2)	DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.

Units	Counts
Participants	OG000

Secondary

Dehydro-aripiprazole (Metabolite) Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR

Time for maximum observed plasma concentration.

PK parameter analysis population. N=number of participants contributing to the mean.

Posted

Median

Full Range

hours

ID	Title	Description
OG000	Aripiprazole 5 mg (Period 1)	Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
OG001	Aripiprazole 5 mg + DVS SR 100 mg (Period 2)	DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.

Units	Counts
Participants

Secondary

Dehydro-aripiprazole (Metabolite) Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR

Terminal half-life is the time measured for the plasma concentration to decrease by one half.

PK parameter analysis population. N=Number of participants contributing to the mean.

Posted

Mean

Standard Deviation

hours

ID	Title	Description
OG000	Aripiprazole 5 mg (Period 1)	Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
OG001	Aripiprazole 5 mg + DVS SR 100 mg (Period 2)	DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.

Units	Counts
Participants

Secondary

Dehydro-aripiprazole (Metabolite) Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR

Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf).

PK parameter analysis population. Data was insufficient for analysis; not analyzable.

Posted

Geometric Mean

Standard Deviation

mL/min

ID	Title	Description
OG000	Aripiprazole 5 mg (Period 1)	Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
OG001	Aripiprazole 5 mg + DVS SR 100 mg (Period 2)	DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.

Units	Counts
Participants

Secondary

Dehydro-aripiprazole (Metabolite) Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR

PK parameter analysis population. Data was insufficient for analysis; not analyzable.

Posted

Geometric Mean

Standard Deviation

liters

ID	Title	Description
OG000	Aripiprazole 5 mg (Period 1)	Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
OG001	Aripiprazole 5 mg + DVS SR 100 mg (Period 2)	DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.

Units	Counts
Participants	OG000

Secondary

Plasma Aripiprazole Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg + Aripiprazole 5 mg

Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.

PK concentration analysis population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period. Period 2 / Day 1 = Day 1 of Aripiprazole dosing (Period 2 / Day 7) within the DVS SR, Aripiprazole coadministration dosing period.

Posted

Median

Full Range

ng/mL

Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing

ID	Title	Description
OG000	Aripiprazole 5 mg (Period 1)	Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
OG001	Aripiprazole 5 mg + DVS SR 100 mg (Period 2)	DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.

Units

Secondary

Plasma Dehydro-aripiprazole (Metabolite) Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg, Aripiprazole 5 mg

Posted

Median

Full Range

ng/mL

Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing

ID	Title	Description
OG000	Aripiprazole 5 mg (Period 1)	Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
OG001	Aripiprazole 5 mg + DVS SR 100 mg (Period 2)	DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukocytosis	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected38 at risk EG0010 affected36 at risk EG0020 affected35 at risk
Tachycardia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected38 at risk EG0010 affected36 at risk EG0020 affected35 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected38 at risk EG0011 affected36 at risk EG0020 affected35 at risk
Lip dry	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected38 at risk EG0011 affected36 at risk EG0020 affected35 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0006 affected38 at risk EG0012 affected36 at risk EG0025 affected35 at risk
Salivary gland pain	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected38 at risk EG0010 affected36 at risk EG0020 affected35 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected38 at risk EG0010 affected36 at risk EG0022 affected35 at risk
Asthenia	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected38 at risk EG0010 affected36 at risk EG0020 affected35 at risk
Chills	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0022 affected35 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected38 at risk EG0010 affected36 at risk EG0020 affected35 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0021 affected35 at risk
Hepatic enzyme increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0021 affected35 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected38 at risk EG0011 affected36 at risk EG0021 affected35 at risk
Dizziness	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected38 at risk EG0010 affected36 at risk EG0021 affected35 at risk
Dysgeusia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected38 at risk EG0011 affected36 at risk EG0021 affected35 at risk
Headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected38 at risk EG0012 affected36 at risk EG0021 affected35 at risk
Paraesthesia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0022 affected35 at risk
Presyncope	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected38 at risk EG0010 affected36 at risk EG0021 affected35 at risk
Attention deficit / hyperactivity disorder	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected38 at risk EG0010 affected36 at risk EG0020 affected35 at risk
Insomnia	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0021 affected35 at risk
Flushing	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected38 at risk EG0010 affected36 at risk EG0020 affected35 at risk
Hot flush	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0007 affected38 at risk EG0010 affected36 at risk EG0020 affected35 at risk
Hypertension	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected38 at risk EG0010 affected36 at risk EG0020 affected35 at risk
Hypotension	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected38 at risk EG0010 affected36 at risk EG0020 affected35 at risk

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015363	Quinolones
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D008055	Lipids

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Aripiprazole 5 mg (Period 1)	Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.	38	14	38
EG001	DVS SR 100 mg (Period 2)	DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state).	36	5	36
EG002	Aripiprazole 5 mg + DVS SR 100 mg (Period 2)	DVS SR as a single oral dose of 100 mg Period 2 / Day 7 though Day 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.	35	9	35