Trial Outcomes & Findings for Safety Study of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension (NCT NCT00686803)
NCT ID: NCT00686803
Last Updated: 2013-07-19
Results Overview
The pharmacokinetic profile parameters for PL-3994 were calculated using a non compartmental approach. •Maximum concentration (Cmax) The subject numbers below are the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK parameters were possible.
COMPLETED
PHASE2
21 participants
24 hours
2013-07-19
Participant Flow
Initiation Date: 28 April 2008 Completion Date: 21 July 2008 Cohort 1: 6 subjects: PL-3994 0.3 µg/kg; 1 subject Placebo Cohort 2: 6 subjects: PL-3994 0.1 µg/kg; 1 subject Placebo Cohort 3: 6 subjects: PL-3994 0.3 µg/kg; 1 subject Placebo; Study stopped after Cohort 3.
Some results (i.e.Pharmacodynamic results) may include analyses only for the Evaluable Subjects population.The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK or PD parameters were possible.
Participant milestones
| Measure |
PL-3994 0.1 µg/kg
PL-3994 0.1 µg/kg
|
PL-3994 0.3 µg/kg
PL-3994 0.3 µg/kg
|
Placebo
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
12
|
3
|
|
Overall Study
COMPLETED
|
6
|
12
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension
Baseline characteristics by cohort
| Measure |
PL-3994 0.1 µg/kg
n=6 Participants
PL-3994 0.1 µg/kg
|
PL-3994 0.3 µg/kg
n=12 Participants
PL-3994 0.3 µg/kg
|
Placebo
n=3 Participants
Placebo
|
Total
n=21 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
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
21 Participants
n=4 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
|
|
Age Continuous
|
53.5 years
STANDARD_DEVIATION 5.24 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 5.42 • n=7 Participants
|
59.3 years
STANDARD_DEVIATION 5.13 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 5.72 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
12 participants
n=7 Participants
|
3 participants
n=5 Participants
|
21 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 hoursThe pharmacokinetic profile parameters for PL-3994 were calculated using a non compartmental approach. •Maximum concentration (Cmax) The subject numbers below are the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK parameters were possible.
Outcome measures
| Measure |
PL-3994 0.1 µg/kg
n=6 Participants
PL-3994 0.1 µg/kg
|
PL-3994 0.3 µg/kg
n=12 Participants
PL-3994 0.3 µg/kg
|
Placebo
n=3 Participants
Placebo
|
|---|---|---|---|
|
Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension.
|
0 ng/mL
Standard Deviation 0
|
0.366 ng/mL
Standard Deviation 0.0656
|
0 ng/mL
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 24 hoursPharmacodynamic parameters were calculated from the baseline-adjusted plasma cGMP level-time data using WinNonlin® 5.0.1. Actual sample times were used in the calculations. Baseline was the pre-dose levels of plasma cGMP at Visit 2 (Day 1): Emax The patient numbers below represent the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PD parameters were possible.
Outcome measures
| Measure |
PL-3994 0.1 µg/kg
n=3 Participants
PL-3994 0.1 µg/kg
|
PL-3994 0.3 µg/kg
n=8 Participants
PL-3994 0.3 µg/kg
|
Placebo
n=1 Participants
Placebo
|
|---|---|---|---|
|
Pharmacodynamics as Measured by cGMP Levels.
|
0.996 ng/mL
Interval 0.38 to 1.03
|
1.435 ng/mL
Interval 0.87 to 4.26
|
0.676 ng/mL
Interval 0.676 to 0.676
|
Adverse Events
PL-3994 0.1 µg/kg
PL-3994 0.3 µg/kg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PL-3994 0.1 µg/kg
n=6 participants at risk
PL-3994 0.1 µg/kg
|
PL-3994 0.3 µg/kg
n=12 participants at risk
PL-3994 0.3 µg/kg
|
Placebo
n=3 participants at risk
Placebo
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
33.3%
4/12
|
33.3%
1/3
|
|
Nervous system disorders
headache
|
0.00%
0/6
|
16.7%
2/12
|
33.3%
1/3
|
|
Nervous system disorders
somnolence
|
0.00%
0/6
|
8.3%
1/12
|
33.3%
1/3
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/3
|
|
Nervous system disorders
dizziness postural
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
General disorders
fatigue
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
General disorders
feeling hot
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
General disorders
Oedema peripheral
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
General disorders
vessel puncture site pain
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
musculoskelatal stiffness
|
0.00%
0/6
|
0.00%
0/12
|
33.3%
1/3
|
|
Investigations
platelet count decreased
|
0.00%
0/6
|
0.00%
0/12
|
33.3%
1/3
|
|
Psychiatric disorders
depersonalization
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Renal and urinary disorders
urinary tract inflammation
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
ecchymosis
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Vascular disorders
hypotension
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
Additional Information
Robert Jordan, Executive Director of Clinical Operations
Palatin Technologies, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee PI was an employed by Palatin, as he was/is an employee of the CRO hired by Palatin to conduct the study. All confidentiality agreed upon between Palatin and the CRO applies.
- Publication restrictions are in place
Restriction type: OTHER