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The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of PF-05175157 in healthy volunteers and patients with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 mg PF-05175157 or Placebo QD | Experimental |
| |
| 100 mg PF-05175157 or Placebo QD | Experimental | Planned dose might be modified based on emerging safety and PK data. |
|
| 200 mg PF-05175157 or Placebo QD | Experimental | Planned dose might be modified based on emerging safety and PK data. |
|
| 100 mg PF-05175157 or Placebo BID | Experimental | Planned dose might be modified based on emerging safety and PK data. |
|
| xxx mg PF-05175157 | Experimental | Dose will be determined based on results obtained from Arms 1 to 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05175157 or Placebo | Drug | One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to PF-05175157 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Research Associates | South Miami | Florida | 33143 | United States | ||
| MRA Clinical Research |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo - Healthy and Overweight Participants (HOV) | HOV participants administered orally matched placebo capsules once daily (QD) for 14 days |
| FG001 | Placebo - Type 2 Diabetes Mellitus Participants (T2DM) | T2DM participants administered orally matched placebo capsules QD for 14 days |
| FG002 | PF-05175157 30 mg QD - HOV | HOV participants administered orally 30 milligram (mg) capsules of PF-05175157 QD for 14 days |
| FG003 | PF-05175157 100 mg QD - HOV | HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days |
| FG004 | PF-05175157 200 mg QD - HOV | HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days |
| FG005 | PF-05175157 100 mg BID - HOV | HOV participants administered orally 100 mg capsules of PF-05175157 twice daily (BID) for 14 days |
| FG006 | PF-05175157 200 mg QD - T2DM | T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo - HOV | HOV participants administered orally matched placebo capsules QD for 14 days |
| BG001 | Placebo - T2DM | T2DM participants administered orally matched placebo capsules QD for 14 days |
| 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 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to PF-05175157 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | Safety Analysis Set: all participants who received at least 1 dose of study medication (PF-05175157 or placebo). | Posted | Number | participants | 2 weeks |
|
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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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo - HOV | HOV participants administered orally matched placebo capsules QD for 14 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| PF-05175157 or Placebo | Drug | One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers. |
|
| PF-05175157 or Placebo | Drug | One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers. |
|
| PF-05175157 or Placebo | Drug | One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule twice daily for 14 days, immediately before breakfast and dinner, in healthy volunteers. |
|
| PF-05175157 or Placebo | Drug | One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once (or twice) daily for 14 days, immediately before breakfast (and dinner), in patients with type 2 diabetes. |
|
| Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 |
| Accumulation Ratio for Area Under the Concentration-Time Curve (Rˇac, AUC) | Rˇac for the AUC is defined as AUC (τ, single dose [ss]) / AUC (τ, multiple dose [sd]). | Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 |
| Renal Clearance (CLr) | CLr is the amount of unchanged drug excreted in the participants urine from time zero to end of dosing interval. | Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 |
| Urinary Recovery | Percentage of PF-05175157 excreted unchanged in urine over the dosing interval. | Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 |
| South Miami |
| Florida |
| 33143 |
| United States |
| Pulmonary Physicians of South Florida | South Miami | Florida | 33143 | United States |
| Other |
|
| BG002 | PF-05175157 30 mg QD - HOV | HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days |
| BG003 | PF-05175157 100 mg QD -HOV | HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days |
| BG004 | PF-05175157 200 mg QD - HOV | HOV participants administered orally 200 mg capsules PF-05175157 QD for 14 days |
| BG005 | PF-05175157 100 mg BID - HOV | HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days |
| BG006 | PF-05175157 200 mg QD - T2DM | T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days |
| BG007 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
T2DM participants administered orally matched placebo capsules QD for 14 days
| OG002 | PF-05175157 30 mg QD - HOV | HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days |
| OG003 | PF-05175157 100 mg QD - HOV | HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days |
| OG004 | PF-05175157 200 mg QD - HOV | HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days |
| OG005 | PF-05175157 100 mg BID - HOV | HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days |
| OG006 | PF-05175157 200 mg QD - T2DM | T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days |
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Pharmacokinetic Concentration (PKC) Analysis Population: all enrolled participants who received at least 1 dose of PF-05175157 and had at least 1 concentration value reported. Number of Participants Analyzed (N): number of participants with evaluable data | Posted | Mean | Standard Deviation | micrograms per milliliter (µg/mL) | Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Pharmacokinetic Parameter (PKP) Analysis Population: all enrolled participante who received at least 1 dose of PF05175157 and had at least 1 PKP of interest calculated;Number of Participants Analyzed (N): number of participants with evaluable data | Posted | Median | Full Range | hours (hrs) | Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 |
|
|
|
| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | PKP analysis population; Participants Analyzed (N): number of participants with evaluable data | Posted | Mean | Standard Deviation | µg times (*)hr divided by mL (µg *hr/mL) | Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 |
|
|
|
| Secondary | Accumulation Ratio for Area Under the Concentration-Time Curve (Rˇac, AUC) | Rˇac for the AUC is defined as AUC (τ, single dose [ss]) / AUC (τ, multiple dose [sd]). | PKP analysis population; Participants Analyzed (N): number of participants with evaluable data | Posted | Mean | Standard Deviation | ratio | Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 |
|
|
|
| Secondary | Renal Clearance (CLr) | CLr is the amount of unchanged drug excreted in the participants urine from time zero to end of dosing interval. | PKP analysis population; Participants Analyzed (N): number of participants with evaluable data | Posted | Mean | Standard Deviation | mL/min | Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 |
|
|
|
| Secondary | Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | It was not possible to calculate data for half-life as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the half-life. | Posted | Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 |
|
|
| Secondary | Urinary Recovery | Percentage of PF-05175157 excreted unchanged in urine over the dosing interval. | PKP analysis population; Participants Analyzed (N): number of participants with evaluable data | Posted | Mean | Standard Deviation | percentage | Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 |
|
|
|
| 0 |
| 12 |
| 2 |
| 12 |
| EG001 | Placebo - T2DM | T2DM participants administered orally matched placebo capsules QD for 14 days | 0 | 5 | 2 | 5 |
| EG002 | PF-05175157 30 mg QD - HOV | HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days | 0 | 9 | 1 | 9 |
| EG003 | PF-05175157 100 mg QD - HOV | HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days | 0 | 9 | 1 | 9 |
| EG004 | PF-05175157 200 mg QD - HOV | HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days | 0 | 9 | 2 | 9 |
| EG005 | PF-05175157 100 mg BID - HOV | HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days | 0 | 9 | 5 | 9 |
| EG006 | PF-05175157 200 mg QD - T2DM | T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days | 0 | 11 | 3 | 11 |
| Conjunctival irritation | Eye disorders | 14.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | 14.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 14.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | 14.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | 14.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 14.0 | Non-systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | 14.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | 14.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | 14.0 | Non-systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | 14.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | 14.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | 14.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | 14.0 | Non-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.
| D004700 | Endocrine System Diseases |