Trial Outcomes & Findings for Multiple Rising Oral Dose Study of PG 760564 Administered Twice Daily to Healthy Male/Female Volunteers for 14 Days (NCT NCT00791388)
NCT ID: NCT00791388
Last Updated: 2011-11-04
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
45 participants
Primary outcome timeframe
14 days
Results posted on
2011-11-04
Participant Flow
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)
Participant milestones
| Measure |
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.
|
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)
|
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)
|
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)
|
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)
|
|---|---|---|---|---|---|
|
Period 1 - 50 mg Dose Group
STARTED
|
3
|
8
|
0
|
0
|
0
|
|
Period 1 - 50 mg Dose Group
COMPLETED
|
3
|
7
|
0
|
0
|
0
|
|
Period 1 - 50 mg Dose Group
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
|
Period 2 - 100 mg Dose Group
STARTED
|
3
|
0
|
8
|
0
|
0
|
|
Period 2 - 100 mg Dose Group
COMPLETED
|
2
|
0
|
8
|
0
|
0
|
|
Period 2 - 100 mg Dose Group
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
|
Period 3 - 200 mg Dose Group
STARTED
|
3
|
0
|
0
|
8
|
0
|
|
Period 3 - 200 mg Dose Group
COMPLETED
|
3
|
0
|
0
|
8
|
0
|
|
Period 3 - 200 mg Dose Group
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 4 - 400 mg Dose Group
STARTED
|
4
|
0
|
0
|
0
|
8
|
|
Period 4 - 400 mg Dose Group
COMPLETED
|
4
|
0
|
0
|
0
|
4
|
|
Period 4 - 400 mg Dose Group
NOT COMPLETED
|
0
|
0
|
0
|
0
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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)
|
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)
|
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)
|
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)
|
|---|---|---|---|---|---|
|
Period 1 - 50 mg Dose Group
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
|
Period 2 - 100 mg Dose Group
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
|
Period 4 - 400 mg Dose Group
Adverse Event
|
0
|
0
|
0
|
0
|
4
|
Baseline Characteristics
Multiple Rising Oral Dose Study of PG 760564 Administered Twice Daily to Healthy Male/Female Volunteers for 14 Days
Baseline characteristics by cohort
| Measure |
Placebo
n=13 Participants
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.
|
50 mg PG 760564
n=8 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)
|
100 mg PG 760564
n=8 Participants
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)
|
200 mg PG 760564
n=8 Participants
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)
|
400 mg PG 760564
n=8 Participants
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)
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age Continuous
|
34.6 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
35.0 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
29.9 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 6.5 • n=4 Participants
|
36.9 years
STANDARD_DEVIATION 5.8 • n=21 Participants
|
34.5 years
STANDARD_DEVIATION 6.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
43 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
8 participants
n=21 Participants
|
45 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: PG 760564 blood plasma concentrations were not measured for the placebo arm
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
Outcome measures
| Measure |
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.
|
50 mg PG 760564
n=7 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)
|
100 mg PG 760564
n=8 Participants
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)
|
200 mg PG 760564
n=8 Participants
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)
|
400 mg PG 760564
n=4 Participants
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)
|
|---|---|---|---|---|---|
|
AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14
|
—
|
12090.998 ng*h/mL
Standard Deviation 2926.950
|
23472.1329 ng*h/mL
Standard Deviation 9858.248
|
30005.781 ng*h/mL
Standard Deviation 9955.931
|
50354.938 ng*h/mL
Standard Deviation 9781.333
|
PRIMARY outcome
Timeframe: 12 hours on Day 14Maximum plasma concentration (Cmax) over a dosing interval (τ = 12 hours)on Day 14
Outcome measures
| Measure |
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.
|
50 mg PG 760564
n=7 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)
|
100 mg PG 760564
n=8 Participants
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)
|
200 mg PG 760564
n=8 Participants
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)
|
400 mg PG 760564
n=4 Participants
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)
|
|---|---|---|---|---|---|
|
Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14
|
—
|
1601.4 ng/mL
Standard Deviation 318.2
|
2951.3 ng/mL
Standard Deviation 1148.2
|
3935.0 ng/mL
Standard Deviation 953.1
|
7195.0 ng/mL
Standard Deviation 279.2
|
PRIMARY outcome
Timeframe: 12 Hours on Day 14the time at which maximum plasma concentration occurred (Tmax) Over a Dosing Interval (τ = 12 Hours) on Day 14
Outcome measures
| Measure |
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.
|
50 mg PG 760564
n=7 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)
|
100 mg PG 760564
n=8 Participants
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)
|
200 mg PG 760564
n=8 Participants
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)
|
400 mg PG 760564
n=4 Participants
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)
|
|---|---|---|---|---|---|
|
Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14
|
—
|
2.46 hours
Standard Deviation 0.98
|
2.89 hours
Standard Deviation 0.63
|
3.01 hours
Standard Deviation 0.54
|
2.03 hours
Standard Deviation 0.82
|
PRIMARY outcome
Timeframe: over a Dosing Interval (τ = 12 Hours) on Day 14t½,z is the terminal exponential half-life; over a Dosing Interval (τ = 12 Hours)on Day 14
Outcome measures
| Measure |
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.
|
50 mg PG 760564
n=7 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)
|
100 mg PG 760564
n=8 Participants
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)
|
200 mg PG 760564
n=8 Participants
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)
|
400 mg PG 760564
n=4 Participants
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)
|
|---|---|---|---|---|---|
|
t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14
|
—
|
9.411 hours
Standard Deviation 2.640
|
7.882 hours
Standard Deviation 1.814
|
10.223 hours
Standard Deviation 3.947
|
9.701 hours
Standard Deviation 1.714
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
50 mg PG 760564
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
100 mg PG 760564
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
200 mg PG 760564
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
400 mg PG 760564
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 |
Placebo
n=13 participants at risk
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.
|
50 mg PG 760564
n=8 participants at risk
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)
|
100 mg PG 760564
n=8 participants at risk
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)
|
200 mg PG 760564
n=8 participants at risk
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)
|
400 mg PG 760564
n=8 participants at risk
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)
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/13
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/13
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/13
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Eye disorders
Ocular discomfort
|
7.7%
1/13 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/13
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/13
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Lip Dry
|
15.4%
2/13 • Number of events 2
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Chapped lips
|
7.7%
1/13 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
|
General disorders
Application site erythema
|
0.00%
0/13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Chills
|
0.00%
0/13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Tenderness
|
0.00%
0/13
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Infections and infestations
Folliculitis
|
0.00%
0/13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Dental caries
|
0.00%
0/13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
|
Infections and infestations
Paronychia
|
0.00%
0/13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Investigations
Faecal occult blood positive
|
15.4%
2/13 • Number of events 2
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/13
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Investigations
White blood cell count increased
|
0.00%
0/13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Nervous system disorders
Lethargy
|
7.7%
1/13 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Nervous system disorders
Headache
|
0.00%
0/13
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
37.5%
3/8 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
7.7%
1/13 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/13
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
15.4%
2/13 • Number of events 2
|
75.0%
6/8 • Number of events 6
|
12.5%
1/8 • Number of events 1
|
87.5%
7/8 • Number of events 7
|
50.0%
4/8 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
1/13 • Number of events 1
|
0.00%
0/8
|
50.0%
4/8 • Number of events 4
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.7%
1/13 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
1/13 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
7.7%
1/13 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Vascular disorders
Hot flush
|
0.00%
0/13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.7%
1/13 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER