Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer

• ClinicalTrials.gov Identifier: NCT03077659
• Recruitment Status: Completed
• First Posted: March 13, 2017
• Results First Posted: August 20, 2019
• Last Update Posted: August 20, 2019
• Sponsor: NanOlogy, LLC
• Collaborator: US Biotest, Inc.
• Information provided by (Responsible Party): NanOlogy, LLC

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Adenocarcinoma of the Prostate
• Intervention: Drug: NanoPac®
• Enrollment: 16

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	NanoPac® 6 mg/mL	NanoPac® 10 mg/mL	NanoPac® 15 mg/mL
Arm/Group Description	NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.	NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.	NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.
Period Title: Overall Study
Started	3	3	10
Completed	3	3	9
Not Completed	0	0	1
Reason Not Completed
Withdrawal by Subject	0	0	1

Baseline Characteristics

Arm/Group Title		NanoPac® 6 mg/mL	NanoPac® 10 mg/mL	NanoPac® 15 mg/mL	Total
Arm/Group Description		NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.	NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.	NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.	Total of all reporting groups
Overall Number of Baseline Participants		3	3	10	16
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	3 participants	3 participants	10 participants	16 participants
		63.0 (12.3)	73.3 (7.8)	63.8 (7.9)	65.4 (9.0)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants	3 participants	10 participants	16 participants
	Female	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Male	3 100.0%	3 100.0%	10 100.0%	16 100.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants	3 participants	10 participants	16 participants
	Hispanic or Latino	1 33.3%	2 66.7%	2 20.0%	5 31.3%
	Not Hispanic or Latino	2 66.7%	1 33.3%	7 70.0%	10 62.5%
	Unknown or Not Reported	0 0.0%	0 0.0%	1 10.0%	1 6.3%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants	3 participants	10 participants	16 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	1 10.0%	1 6.3%
	White	3 100.0%	2 66.7%	8 80.0%	13 81.3%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	1 33.3%	1 10.0%	2 12.5%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	3 participants	3 participants	10 participants	16 participants
		3	3	10	16

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)
Description	Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.
Time Frame	Day 1 to Day 29

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	NanoPac® 6 mg/mL	NanoPac® 10 mg/mL	NanoPac® 15 mg/mL
Arm/Group Description:	NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.	NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.	NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.
Overall Number of Participants Analyzed	3	3	10
Measure Type: Count of Participants; Unit of Measure: Participants
All TEAEs	3 100.0%	2 66.7%	6 60.0%
Possibly Related TEAEs	3 100.0%	0 0.0%	1 10.0%

2. Secondary Outcome

Title	Tumor Response Based on Change in Image Volume on mpMRI
Description	Tumor response to treatment with NanoPac was determined by evaluating the change in image volume with multiparametric MRI (mpMRI) within three months prior to consent and again within 48 hours of the prostatectomy procedure (Day 29). In those cases where two dimensions/axes were available, width was imputed to height for the purposes of calculation, i.e. the lesion was assumed to be an oblate spheroid. In those cases where only one dimension/axis was available, that dimension/axis was imputed for all three dimensions i.e. the lesion was assumed to be a sphere. For this reason, analyses were performed for all subjects with two dimensions available, as well as those for which at least one dimension was available. The data presented for this outcome measure is the one dimension lesion volume calculation: Lesion Volume (cc) = (3.14/6)*(length)³, where length is the longer or only measured dimension.
Time Frame	Up to three months prior to consent and Day 29

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	NanoPac® 6 mg/mL	NanoPac® 10 mg/mL	NanoPac® 15 mg/mL
Arm/Group Description:	NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.	NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.	NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.
Overall Number of Participants Analyzed	3	3	9
Mean (Standard Deviation); Unit of Measure: cc
Lesion Volume at Screening	3.19 (1.46)	0.89 (0.44)	4.89 (5.12)
Lesion Volume at Day 29	1.80 (0.98)	1.91 (1.50)	5.10 (7.79)

3. Secondary Outcome

Title	Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score)
Description	Prostate tissue samples were obtained via biopsy at baseline and immediately prior to prostatectomy (Day 29). Histologic evaluation of these samples was used to determine the Gleason score, and the results at baseline and Day 29 were used to evaluate the tumor response to treatment with NanoPac®. The Gleason score is calculated by adding together the two grades of cancer cells that make up the largest areas of the biopsied tissue sample. The Gleason score usually ranges from 6 to 10. The lower the Gleason score, the more the cancer cells look like normal cells and are likely to grow and spread slowly; a higher Gleason score is likely to indicate a worse outcome. The Gleason score is used to help plan treatment and determine prognosis.
Time Frame	Screening and Day 29

Outcome Measure Data

Analysis Population Description

Full Analysis set

Arm/Group Title	NanoPac® 6 mg/mL	NanoPac® 10 mg/mL	NanoPac® 15 mg/mL
Arm/Group Description:	NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.	NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.	NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.
Overall Number of Participants Analyzed	3	3	10
Mean (Standard Deviation); Unit of Measure: score on a scale
Gleason Score at Screening	7.7 (1.2)	7.0 (0.0)	7.4 (0.7)
Gleason Score at Day 29	7.7 (1.2)	7.0 (0.0)	7.1 (0.9)

4. Secondary Outcome

Title	Percentage of Sample Considered Adenocarcinoma
Description	Tissues excised from the primary tumor during prostatectomy (Day 29) were evaluated for the percentage considered adenocarcinoma
Time Frame	Day 29 (prostatectomy)

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	NanoPac® 6 mg/mL	NanoPac® 10 mg/mL	NanoPac® 15 mg/mL
Arm/Group Description:	NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.	NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.	NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.
Overall Number of Participants Analyzed	3	3	10
Mean (Standard Deviation); Unit of Measure: percentage of sample adenocarcinoma
Primary Tumor at Screening	53.3 (5.8)	33.3 (24.7)	47.5 (22.0)
Primary Tumor at Day 29	25.0 (15.0)	56.7 (25.2)	42.5 (28.0)

5. Secondary Outcome

Title	Concentration of Paclitaxel in the Systemic Circulation
Description	Pharmacokinetic samples were taken on Day 1 at 1, 2, 4, and 6 hours post-injection, and weekly until prostatectomy. All numeric paclitaxel concentration data above the Lower Limit of Quantitation (25 pg/mL) was tabulated by cohort.
Time Frame	Day 1, Day 8, Day 15, Day 22, and Day 29

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	NanoPac® 6 mg/mL	NanoPac® 10 mg/mL	NanoPac® 15 mg/mL
Arm/Group Description:	NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume.	NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume.	NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume.
Overall Number of Participants Analyzed	3	3	10
Mean (Standard Deviation); Unit of Measure: Plasma paclitaxel concentration (pg/mL)
Day 1 - 1 hr Post-Injection	5590.00 (2312.336)	19673.33 (20736.445)	19010.50 (15105.857)
Day 1 - 2 hr Post-Injection	3483.33 (1851.657)	9103.33 (7881.982)	12948.70 (10230.061)
Day 1 - 4 hr Post-Injection	2240.00 (756.241)	4740.00 (3889.884)	6830.80 (5219.617)
Day 1 - 6 hr Post-Injection	1926.67 (823.549)	5006.67 (4938.181)	5109.00 (3544.025)
Day 8	177.10 (102.777)	234.33 (73.446)	404.25 (221.326)
Day 15	65.10 (24.974)	82.85 (7.283)	106.11 (62.626)
Day 22	55.70 (15.556)	43.05 (16.051)	86.63 (52.358)
Day 29	35.45 (14.496)	54.75 (36.275)	57.64 (29.269)

6. Post-Hoc Outcome

Title	Change in PSA Density
Description	PSA density was measured with mpMRI
Time Frame	Screening and Day 29

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	NanoPac® 6 mg/mL	NanoPac® 10 mg/mL	NanoPac® 15 mg/mL
Arm/Group Description:	NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.	NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.	NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.
Overall Number of Participants Analyzed	3	3	10
Mean (Standard Deviation); Unit of Measure: ng/mL/cc
PSA Density at Screening	3.64 (5.75)	0.23 (0.02)	0.31 (0.31)
PSA Density at Day 29	1.95 (2.84)	0.20 (0.01)	0.20 (0.11)

7. Post-Hoc Outcome

Title	Change in PI-RADS Score
Description	The Prostate Imaging Reporting and Data System (PI-RADS) assessment uses a five-point scale based on the probability that a combination of mpMRI findings on T2 weighting (T2W), Diffusion Weighted Imaging (DWI), and Dynamic Contrast Enhancement (DCE) correlates with the presence of a clinically significant cancer in the prostate gland. A PI-RADS score of 1 is considered to be most probably benign and a score of 5 is considered to be highly suspicious of a prostate malignancy. PI-RADS 1: very low (clinically significant cancer is highly unlikely to be present); PI-RADS 2: low (clinically significant cancer is unlikely to be present); PI-RADS 3: intermediate (presence of clinically significant cancer is equivocal); PI-RADS 4: high (clinically significant cancer is likely to be present); PI-RADS 5: very high (clinically significant cancer is highly likely to be present).
Time Frame	Screening and Day 29

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	NanoPac® 6 mg/mL	NanoPac® 10 mg/mL	NanoPac® 15 mg/mL
Arm/Group Description:	NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.	NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.	NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.
Overall Number of Participants Analyzed	3	3	10
Measure Type: Count of Participants; Unit of Measure: Participants
PI-RADS 3 : Screening	1 33.3%	1 33.3%	1 10.0%
PI-RADS 3 : Day 29	0 0.0%	0 0.0%	2 20.0%
PI-RADS 4 : Screening	0 0.0%	1 33.3%	5 50.0%
PI-RADS 4 : Day 29	1 33.3%	2 66.7%	2 20.0%
PI-RADS 5 : Screening	2 66.7%	1 33.3%	4 40.0%
PI-RADS 5 : Day 29	2 66.7%	1 33.3%	6 60.0%

8. Post-Hoc Outcome

Title	Tumor Invasion Into Surrounding Tissues
Description	Assessed histologically after TRUS biopsy at Screening and on Day 29 prior to prostatectomy.
Time Frame	Screening and Day 29

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	NanoPac® 6 mg/mL	NanoPac® 10 mg/mL	NanoPac® 15 mg/mL
Arm/Group Description:	NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.	NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.	NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.
Overall Number of Participants Analyzed	3	3	10
Measure Type: Count of Participants; Unit of Measure: Participants
Any invasion at Screening? Yes	2 66.7%	0 0.0%	4 40.0%
Any invasion at Screening? No	1 33.3%	3 100.0%	6 60.0%
Any invasion at Day 29? Yes	2 66.7%	2 66.7%	2 20.0%
Any invasion at Day 29? No	1 33.3%	1 33.3%	8 80.0%

Adverse Events

Time Frame	28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy)
Adverse Event Reporting Description	Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Arm/Group Title	NanoPac® 6 mg/mL		NanoPac® 10 mg/mL		NanoPac® 15 mg/mL
Arm/Group Description	NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.		NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.		NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.
All-Cause Mortality
	NanoPac® 6 mg/mL		NanoPac® 10 mg/mL		NanoPac® 15 mg/mL
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/3 (0.00%)		0/3 (0.00%)		0/10 (0.00%)
Serious Adverse Events
	NanoPac® 6 mg/mL		NanoPac® 10 mg/mL		NanoPac® 15 mg/mL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0.00%)		0/3 (0.00%)		0/10 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	NanoPac® 6 mg/mL		NanoPac® 10 mg/mL		NanoPac® 15 mg/mL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100.00%)		2/3 (66.67%)		6/10 (60.00%)
Blood and lymphatic system disorders
Anemia * 1	2/3 (66.67%)	2	0/3 (0.00%)	0	1/10 (10.00%)	1
Leucocystosis † 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/10 (0.00%)	0
Eye disorders
Vision Blurred † 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/10 (0.00%)	0
Gastrointestinal disorders
Abdominal distension † 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/10 (0.00%)	0
Abdominal Pain † 1	2/3 (66.67%)	2	0/3 (0.00%)	0	0/10 (0.00%)	0
Constipation † 1	1/3 (33.33%)	1	1/3 (33.33%)	1	0/10 (0.00%)	0
Diarrhoea † 1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/10 (10.00%)	1
Dry mouth † 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/10 (0.00%)	0
Gastroesophageal reflux disease † 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/10 (0.00%)	0
Ileus † 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/10 (0.00%)	0
Nausea † 1	2/3 (66.67%)	2	0/3 (0.00%)	0	2/10 (20.00%)	2
Procalgia † 1	2/3 (66.67%)	2	0/3 (0.00%)	0	1/10 (10.00%)	1
Vomiting † 1	0/3 (0.00%)	0	0/3 (0.00%)	0	2/10 (20.00%)	2
General disorders
Fatigue † 1	3/3 (100.00%)	5	0/3 (0.00%)	0	0/10 (0.00%)	0
Local swelling † 1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/10 (10.00%)	1
Oedema peripheral † 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/10 (0.00%)	0
Infections and infestations
Viral URTI † 1	0/3 (0.00%)	0	1/3 (33.33%)	1	0/10 (0.00%)	0
Injury, poisoning and procedural complications
Procedural pain † 1	0/3 (0.00%)	0	0/3 (0.00%)	0	4/10 (40.00%)	4
Wound complication † 1	0/3 (0.00%)	0	1/3 (33.33%)	1	0/10 (0.00%)	0
Metabolism and nutrition disorders
Decreased appetite † 1	2/3 (66.67%)	2	0/3 (0.00%)	0	0/10 (0.00%)	0
Hperglycaemia † 1	1/3 (33.33%)	1	0/3 (0.00%)	0	1/10 (10.00%)	1
Hypokalaemia † 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/10 (0.00%)	0
Musculoskeletal and connective tissue disorders
Arthralgia † 1	1/3 (33.33%)	2	0/3 (0.00%)	0	0/10 (0.00%)	0
Bone pain † 1	1/3 (33.33%)	2	1/3 (33.33%)	1	0/10 (0.00%)	0
Myalgia † 1	1/3 (33.33%)	2	0/3 (0.00%)	0	0/10 (0.00%)	0
Nervous system disorders
Dizziness † 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/10 (0.00%)	0
Headache † 1	0/3 (0.00%)	0	0/3 (0.00%)	0	2/10 (20.00%)	2
Lethargy † 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/10 (0.00%)	0
Memory impairment † 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/10 (0.00%)	0
Somnolence † 1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/10 (10.00%)	1
Tremor † 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/10 (0.00%)	0
Psychiatric disorders
Anxiety † 1	1/3 (33.33%)	1	1/3 (33.33%)	1	1/10 (10.00%)	1
Insomnia † 1	1/3 (33.33%)	3	0/3 (0.00%)	0	0/10 (0.00%)	0
Renal and urinary disorders
Dysuria † 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/10 (0.00%)	0
Haematuria † 1	0/3 (0.00%)	0	1/3 (33.33%)	1	1/10 (10.00%)	1
Micturition urgency † 1	1/3 (33.33%)	1	1/3 (33.33%)	1	0/10 (0.00%)	0
Nocturia † 1	1/3 (33.33%)	1	1/3 (33.33%)	1	0/10 (0.00%)	0
Pollakiuria † 1	1/3 (33.33%)	2	0/3 (0.00%)	0	0/10 (0.00%)	0
Urine flow decreased † 1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/10 (10.00%)	1
Reproductive system and breast disorders
Erectile dysfunction † 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/10 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Cough * 1	0/3 (0.00%)	0	1/3 (33.33%)	1	0/10 (0.00%)	0
Vascular disorders
Hypertension † 1	0/3 (0.00%)	0	1/3 (33.33%)	2	1/10 (10.00%)	1
1 Term from vocabulary, MedDRA 20.0; * Indicates events were collected by non-systematic assessment; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Gere S. diZerega, MD
• Organization: NanOlogy, LLC
• Phone: 805-595-1300
• EMail: gere.dizerega@usbiotest.com

• Responsible Party: NanOlogy, LLC
• ClinicalTrials.gov Identifier: NCT03077659
• Other Study ID Numbers: NANOPAC-2016-02
• First Submitted: February 28, 2017
• First Posted: March 13, 2017
• Results First Submitted: July 2, 2019
• Results First Posted: August 20, 2019
• Last Update Posted: August 20, 2019