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This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses).
This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses). The study is a multiple rising dose (MRD) study of active drug vs. placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | placebo capsule |
|
| 50 mg PG 760564 | Experimental | 50 mg PG 760564 active |
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| 100 mg PG 760564 | Experimental | 100 mg PG 760564 active |
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| 200 mg PG 760564 | Experimental | 200 mg PG 760564 active |
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| 400 mg PG 760564 | Experimental | 400 mg PG 760564 active |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | oral capsule, 2x/day for 14 days |
| |
| PG-760564 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14 | the area under the plasma concentration-time curve over a dosing interval (τ = 12 hours) on Day 14 of Multiple Dose Oral Administration of PG-760564 Given Every 12 Hours | 14 days |
| Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14 | Maximum plasma concentration (Cmax) over a dosing interval (τ = 12 hours)on Day 14 | 12 hours on Day 14 |
| Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14 | the time at which maximum plasma concentration occurred (Tmax) Over a Dosing Interval (τ = 12 Hours) on Day 14 | 12 Hours on Day 14 |
| t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14 | t½,z is the terminal exponential half-life; over a Dosing Interval (τ = 12 Hours)on Day 14 | over a Dosing Interval (τ = 12 Hours) on Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William S Aronstein, MD, PhD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stuart I Harris, MD, PhD | Miami | Florida | 33126 | United States |
Each Subject enrolled in the study, participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only. |
| FG001 | 50 mg PG 760564 | 50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups) |
| FG002 | 100 mg PG 760564 | 100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups) |
| FG003 | 200 mg PG 760564 | 200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups) |
| FG004 | 400 mg PG 760564 | 400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - 50 mg Dose Group |
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| Period 2 - 100 mg Dose Group |
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| Period 3 - 200 mg Dose Group |
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| Period 4 - 400 mg Dose Group |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only. |
| BG001 | 50 mg PG 760564 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a single period (i.e., no subject participated in more than one period) |
| 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 | AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14 | the area under the plasma concentration-time curve over a dosing interval (τ = 12 hours) on Day 14 of Multiple Dose Oral Administration of PG-760564 Given Every 12 Hours | PG 760564 blood plasma concentrations were not measured for the placebo arm | Posted | Mean | Standard Deviation | ng*h/mL | 14 days |
|
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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 | placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymph node pain | Blood and lymphatic system disorders | MeDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Thomas | Procter & Gamble | 513.622.4838 | thomas.pr@pg.com |
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| Drug |
oral capsule, 50 mg, 2x/day for 14 days |
|
| PG-760564 | Drug | oral capsule, 100mg, 2x/day for 14 days |
|
| PG-760564 | Drug | oral capsule, 200 mg, 2x/day for 14 days |
|
| PG-760564 | Drug | oral capsule, 400 mg, 2x/day for 14 days |
|
| COMPLETED |
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| NOT COMPLETED |
|
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| COMPLETED |
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| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups) |
| BG002 | 100 mg PG 760564 | 100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups) |
| BG003 | 200 mg PG 760564 | 200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups) |
| BG004 | 400 mg PG 760564 | 400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups) |
| BG005 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age Continuous | This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a single period (i.e., no subject participated in more than one period) | Mean | Standard Deviation | years |
|
| Sex: Female, Male | This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a single period (i.e., no subject participated in more than one period) | Count of Participants | Participants |
|
| Region of Enrollment | This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a single period (i.e., no subject participated in more than one period) | Number | participants |
|
50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
| OG002 | 100 mg PG 760564 | 100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups) |
| OG003 | 200 mg PG 760564 | 200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups) |
| OG004 | 400 mg PG 760564 | 400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups) |
|
|
| Primary | Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14 | Maximum plasma concentration (Cmax) over a dosing interval (τ = 12 hours)on Day 14 | Posted | Mean | Standard Deviation | ng/mL | 12 hours on Day 14 |
|
|
|
| Primary | Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14 | the time at which maximum plasma concentration occurred (Tmax) Over a Dosing Interval (τ = 12 Hours) on Day 14 | Posted | Mean | Standard Deviation | hours | 12 Hours on Day 14 |
|
|
|
| Primary | t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14 | t½,z is the terminal exponential half-life; over a Dosing Interval (τ = 12 Hours)on Day 14 | Posted | Mean | Standard Deviation | hours | over a Dosing Interval (τ = 12 Hours) on Day 14 |
|
|
|
| 0 |
| 13 |
| 7 |
| 13 |
| EG001 | 50 mg PG 760564 | 50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups) | 0 | 8 | 7 | 8 |
| EG002 | 100 mg PG 760564 | 100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups) | 0 | 8 | 7 | 8 |
| EG003 | 200 mg PG 760564 | 200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups) | 0 | 8 | 8 | 8 |
| EG004 | 400 mg PG 760564 | 400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups) | 0 | 8 | 8 | 8 |
| Thrombocytopenia | Blood and lymphatic system disorders | MeDRA | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MeDRA | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MeDRA | Non-systematic Assessment |
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| Ocular discomfort | Eye disorders | MeDRA | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MeDRA | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MeDRA | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MeDRA | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MeDRA | Non-systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MeDRA | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MeDRA | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MeDRA | Non-systematic Assessment |
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| Lip Dry | Gastrointestinal disorders | MeDRA | Non-systematic Assessment |
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| Chapped lips | Gastrointestinal disorders | MeDRA | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MeDRA | Non-systematic Assessment |
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| Application site erythema | General disorders | MeDRA | Non-systematic Assessment |
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| Chills | General disorders | MeDRA | Non-systematic Assessment |
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| Pyrexia | General disorders | MeDRA | Non-systematic Assessment |
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| Tenderness | General disorders | MeDRA | Non-systematic Assessment |
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| Folliculitis | Infections and infestations | MeDRA | Non-systematic Assessment |
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| Clostridium colitis | Infections and infestations | MeDRA | Non-systematic Assessment |
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| Dental caries | Infections and infestations | MeDRA | Non-systematic Assessment |
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| Paronychia | Infections and infestations | MeDRA | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MeDRA | Non-systematic Assessment |
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| Faecal occult blood positive | Investigations | MeDRA | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MeDRA | Systematic Assessment |
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| White blood cell count increased | Investigations | MeDRA | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MeDRA | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MeDRA | Non-systematic Assessment |
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| Lethargy | Nervous system disorders | MeDRA | Non-systematic Assessment |
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| Headache | Nervous system disorders | MeDRA | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MeDRA | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MeDRA | Non-systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MeDRA | Non-systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MeDRA | Non-systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MeDRA | Non-systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MeDRA | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MeDRA | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MeDRA | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MeDRA | Non-systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MeDRA | Non-systematic Assessment |
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| Hot flush | Vascular disorders | MeDRA | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MeDRA | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MeDRA | Non-systematic Assessment |
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Data, calculations, interpretations, opinions, and recommendations are the property of P&GP. In the event study results are published in the scientific literature by P&GP, acknowledgment will be made to the Investigator(s) in the accepted style, as appropriate.