Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B2061001 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to evaluate the effect of desvenlafaxine administered as DVS SR on the pharmacokinetics of midazolam in healthy male and female subjects. The amount of drug in the body and the effect of the drug will also be evaluated.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DVS SR | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desvenlafaxine Succinate Sustained Release | Drug | 50 mg DVS SR tablet days 1-6, period 2 only. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Midazolam Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR | AUCinf measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL). | Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
| Midazolam Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR | Cmax measured as nanograms per milliliters (ng/mL). | Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
| 1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR | 1-Hydroxy-Midazolam is an analyte of Midazolam. | Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
| 1-Hydroxy-Midazolam (Analyte) Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR | Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Midazolam Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR | Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing | |
| Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DVS SR 50 mg, Midazolam 4 mg | Midazolam (MDZ) 4 milligram (mg) syrup (2 mg per milliliter [mg/mL]) as a single oral dose Period 1 / Day 1. Desvenlafaxine sustained-release formulation (DVS SR) 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: MDZ Alone |
| |||||||||||||
| Period 2: Coadministration DVS SR, MDZ |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DVS SR 50 mg, Midazolam 4 mg | Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1. DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Midazolam Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR | AUCinf measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL). | PK parameter analysis population: all enrolled 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 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
|
Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
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. Participants are counted for each treatment sequence.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Midazolam 4 mg (Period 1) | Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Midazolam |
| Drug |
4 mg midazolam (2 mL midazolam syrup) day 1, period 1 and day 6, period 2. |
|
| Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
| Midazolam Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR | Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
| 1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR | Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
| 1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR | Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
| 1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR | Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| DVS SR 50 mg, Midazolam 4 mg (Period 2) |
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6. |
|
|
|
| Primary | Midazolam Maximum Observed Plasma Concentration (Cmax) Following Midazolam 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 | Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
|
|
|
|
| Primary | 1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR | 1-Hydroxy-Midazolam is an analyte of Midazolam. | PK parameter analysis population; N=number of participants contributing to the mean. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
|
|
|
|
| Primary | 1-Hydroxy-Midazolam (Analyte) Maximum Observed Plasma Concentration (Cmax) Following Midazolam 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 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
|
|
|
|
| Secondary | Midazolam Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam 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*hr/mL | Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
|
|
|
|
| Secondary | Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR | PK parameter analysis population; N=number of participants contributing to the median. | Posted | Median | Full Range | hr | Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
|
|
|
| Secondary | Midazolam Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR | PK parameter analysis population; N=number of participants contributing to the mean. | Posted | Mean | Standard Deviation | hr | Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
|
|
|
| Secondary | 1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam 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*hr/mL | Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
|
|
|
|
| Secondary | 1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR | PK parameter analysis population; N=number of participants contributing to the median. | Posted | Median | Full Range | hr | Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
|
|
|
| Secondary | 1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR | PK parameter analysis population; N=number of participants contributing to the mean. | Posted | Mean | Standard Deviation | hr | Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing |
|
|
|
| 0 |
| 28 |
| 21 |
| 28 |
| EG001 | DVS SR 50 mg (Period 2 / Day 1 to Day 5) | DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state). | 0 | 28 | 16 | 28 |
| EG002 | DVS SR 50 mg + Midazolam 4 mg (Period 2 / Day 6) | DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6. | 0 | 28 | 24 | 28 |
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Feeling of relaxation | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hunger | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Middle insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Urine flow decreased | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
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.
| D001519 |
| Behavior |
| D006571 | Heterocyclic Compounds |