Trial Outcomes & Findings for Safety and Pharmacokinetics of an Extract of Naringenin (NCT NCT03582553)
NCT ID: NCT03582553
Last Updated: 2020-01-18
Results Overview
All adverse events will be recorded following the first administration of the study product or placebo. The study physician in consultation with the coordinator will review and determine whether a subject can be administered the next ascending dose. The cohorts will be run in series. There will be an interval of up to four weeks between the two cohorts. During this time an interim analysis will be conducted and a safety summary of adverse events for Cohort 1 will be compiled and reviewed by the investigators. Dose safety will be investigated by compiling by treatment (e.g. 150 mg dose, 300 mg dose, placebo) a list of adverse events. The frequency of these events will be counted and compared with the placebo group.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
Results posted on
2020-01-18
Participant Flow
38 subjects were screened for eligibility between May 25, 2018 and September 12, 2018.
Of the 38 participants screened, 10 participants did not meet the study criteria, 7 had schedule conflicts and declined to participate, and 3 were screened before the study was determined to have met the recruiting goal. 18 participants were randomized.
Participant milestones
| Measure |
Cohort 1: NAR150, Placebo, NAR300
Cohort 1 Sequence 1: NAR150 first, then Placebo, then NAR300. 150 and 300 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 300 mg (NAR300) naringenin doses were provided in two capsules. The placebo capsules contained microcystalline cellulose and were similar in appearance.
|
Cohort 1: NAR150, NAR300, Placebo,
Cohort 1 Sequence 2: NAR150 first, then NAR300 and then Placebo. 150 and 300 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 300 mg (NAR300) naringenin doses were provided in two capsules. The placebo capsules contained microcystalline cellulose and were similar in appearance.
|
Cohort 1: Placebo, NAR150, NAR300
Cohort 1 Sequence 3: Placebo first, then NAR150, and then NAR300. 150 and 300 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 300 mg (NAR300) naringenin doses were provided in two capsules. The placebo capsules contained microcystalline cellulose and were similar in appearance.
|
Cohort 2. NAR600, Placebo, NAR900
Cohort 2 Sequence 1: NAR600, then Placebo, and then NAR300. 600 and 900 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 600 mg (NAR600) and 900 mg (NAR900) doses of naringenin were provided in four and six 150 mg capsules respectively. The placebo capsules contained microcystalline cellulose and were similar in appearance.
|
Cohort 2: NAR600, NAR900, Placebo
Cohort 2 Sequence 2: NAR600, then NAR900, and then Placebo. 600 and 900 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 600 mg (NAR600) and 900 mg (NAR900) doses of naringenin were provided in four and six 150 mg capsules respectively. The placebo capsules contained microcystalline cellulose and were similar in appearance.
|
Cohort 2: Placebo, NAR600, NAR900
Cohort 2 Sequence 3: Placebo, NAR600, and then NAR300. 600 and 900 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 600 mg (NAR600) and 900 mg (NAR900) doses of naringenin were provided in four and six 150 mg capsules respectively. The placebo capsules contained microcystalline cellulose and were similar in appearance.
|
|---|---|---|---|---|---|---|
|
Intervention 1/Visit 1
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Intervention 1/Visit 1
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Intervention 1/Visit 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period ( At Least 1 Week)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout Period ( At Least 1 Week)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout Period ( At Least 1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention 2/Visit 2
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Intervention 2/Visit 2
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Intervention 2/Visit 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period (At Least 1 Week)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout Period (At Least 1 Week)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout Period (At Least 1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention 3/Visit 3
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Intervention 3/Visit 3
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Intervention 3/Visit 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Pharmacokinetics of an Extract of Naringenin
Baseline characteristics by cohort
| Measure |
Cohort 1: NAR150, Placebo, NAR300
n=3 Participants
Cohort 1 Sequence 1: NAR150 first, then Placebo, then NAR300. 150 and 300 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 300 mg (NAR300) naringenin doses were provided in two capsules. The placebo capsules contained microcystalline cellulose and were similar in appearance.
|
Cohort 1: NAR150, NAR300, Placebo
n=3 Participants
Cohort 1 Sequence 2: NAR150 first, then NAR300 and then Placebo. 150 and 300 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 300 mg (NAR300) naringenin doses were provided in two capsules. The placebo capsules contained microcystalline cellulose and were similar in appearance.
|
Cohort 1: Placebo, NAR150, NAR300
n=3 Participants
Cohort 1 Sequence 3: Placebo first, then NAR150, and then NAR300. 150 and 300 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 300 mg (NAR300) naringenin doses were provided in two capsules. The placebo capsules contained microcystalline cellulose and were similar in appearance.
|
Cohort 2. NAR600, Placebo, NAR900
n=3 Participants
Cohort 2 Sequence 1: NAR600, then Placebo, and then NAR300. 600 and 900 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 600 mg (NAR600) and 900 mg (NAR900) doses of naringenin were provided in four and six 150 mg capsules respectively. The placebo capsules contained microcystalline cellulose and were similar in appearance.
|
Cohort 2: NAR600, NAR900, Placebo
n=3 Participants
Cohort 2 Sequence 2: NAR600, then NAR900, and then Placebo. 600 and 900 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 600 mg (NAR600) and 900 mg (NAR900) doses of naringenin were provided in four and six 150 mg capsules respectively. The placebo capsules contained microcystalline cellulose and were similar in appearance.
|
Cohort 2: Placebo, NAR600, NAR900
n=3 Participants
Cohort 2 Sequence 3: Placebo, NAR600, and then NAR300. 600 and 900 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 600 mg (NAR600) and 900 mg (NAR900) doses of naringenin were provided in four and six 150 mg capsules respectively. The placebo capsules contained microcystalline cellulose and were similar in appearance.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.33 Years
STANDARD_DEVIATION 16.36 • n=5 Participants
|
48.0 Years
STANDARD_DEVIATION 27.71 • n=7 Participants
|
33 Years
STANDARD_DEVIATION 19.05 • n=5 Participants
|
37.0 Years
STANDARD_DEVIATION 21.36 • n=4 Participants
|
30.67 Years
STANDARD_DEVIATION 17.70 • n=21 Participants
|
55.33 Years
STANDARD_DEVIATION 31.94 • n=8 Participants
|
38.0 Years
STANDARD_DEVIATION 15.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=8 Participants
|
|
Serum Naringenin Concentrations
|
0.02 uM
STANDARD_DEVIATION 0.01 • n=5 Participants
|
0.01 uM
STANDARD_DEVIATION 0 • n=7 Participants
|
0 uM
STANDARD_DEVIATION 0 • n=5 Participants
|
0 uM
STANDARD_DEVIATION 0 • n=4 Participants
|
0 uM
STANDARD_DEVIATION 0 • n=21 Participants
|
0 uM
STANDARD_DEVIATION 0 • n=8 Participants
|
0.008 uM
STANDARD_DEVIATION 0.004 • n=8 Participants
|
PRIMARY outcome
Timeframe: Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.Population: Subjects who completed the study
All adverse events will be recorded following the first administration of the study product or placebo. The study physician in consultation with the coordinator will review and determine whether a subject can be administered the next ascending dose. The cohorts will be run in series. There will be an interval of up to four weeks between the two cohorts. During this time an interim analysis will be conducted and a safety summary of adverse events for Cohort 1 will be compiled and reviewed by the investigators. Dose safety will be investigated by compiling by treatment (e.g. 150 mg dose, 300 mg dose, placebo) a list of adverse events. The frequency of these events will be counted and compared with the placebo group.
Outcome measures
| Measure |
150 mg Dose
n=4 Participants
Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 150 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
300 mg Dose
n=4 Participants
Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 300 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
600 mg Dose
n=2 Participants
Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 600 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
900 mg Dose
n=1 Participants
Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 900 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin.
|
Placebo
n=4 Participants
Subjects in the first cohort will receive 150 mg and 300 mg ascending doses of naringenin and subjects in the second cohort will receive 600 mg and 900 mg ascending doses of naringenin. Each cohort will also have a placebo group.
|
|---|---|---|---|---|---|
|
Incidence of Treatment-emergent Adverse Events Following a Single Dose of a Citrus Extract of Naringenin
Skin and Subcutaneous Tissue Disorders
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events Following a Single Dose of a Citrus Extract of Naringenin
Gastrointestinal
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events Following a Single Dose of a Citrus Extract of Naringenin
Musculoskeletal
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events Following a Single Dose of a Citrus Extract of Naringenin
Nervous System Disorders
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events Following a Single Dose of a Citrus Extract of Naringenin
Respiratory
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events Following a Single Dose of a Citrus Extract of Naringenin
Eye Disorders
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hoursPopulation: Subjects who completed the study
Blood will be drawn over a period of 24 hours following ingestion of the 150 and 600mg doses of naringenin and serum concentrations will be measured. The area under the serum concentration versus time curve will be determined.
Outcome measures
| Measure |
150 mg Dose
n=9 Participants
Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 150 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
300 mg Dose
n=9 Participants
Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 300 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
600 mg Dose
n=18 Participants
Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 600 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
900 mg Dose
Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 900 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin.
|
Placebo
Subjects in the first cohort will receive 150 mg and 300 mg ascending doses of naringenin and subjects in the second cohort will receive 600 mg and 900 mg ascending doses of naringenin. Each cohort will also have a placebo group.
|
|---|---|---|---|---|---|
|
Measurement of Area Under the Serum Naringenin Concentration Versus Time Curve at 150 and 600 mg Doses
|
18.41 (ug/mL) x hour
Standard Error 6.61
|
54.19 (ug/mL) x hour
Standard Error 6.61
|
0.08 (ug/mL) x hour
Standard Error 6.61
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hoursBlood will be drawn over a period of 24 hours following ingestion of the 150 and 600mg doses of naringenin and serum concentrations will be measured. The maximal serum concentration will be determined.
Outcome measures
| Measure |
150 mg Dose
n=9 Participants
Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 150 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
300 mg Dose
n=9 Participants
Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 300 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
600 mg Dose
n=18 Participants
Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 600 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
900 mg Dose
Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 900 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin.
|
Placebo
Subjects in the first cohort will receive 150 mg and 300 mg ascending doses of naringenin and subjects in the second cohort will receive 600 mg and 900 mg ascending doses of naringenin. Each cohort will also have a placebo group.
|
|---|---|---|---|---|---|
|
Measurement of Maximal Concentration of Serum Naringenin at 150 and 600 mg Doses
|
4.29 ug/mL
Standard Error 2.15
|
13.19 ug/mL
Standard Error 2.15
|
0.009 ug/mL
Standard Error 2.15
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Subjects who completed the study
Blood will be drawn over a period of 24 hours following ingestion of the 150 and 600mg doses of naringenin and serum naringenin concentrations will be measured. The time to peak serum naringenin concentration will be determined.
Outcome measures
| Measure |
150 mg Dose
n=9 Participants
Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 150 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
300 mg Dose
n=9 Participants
Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 300 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
600 mg Dose
n=18 Participants
Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 600 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
900 mg Dose
Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 900 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin.
|
Placebo
Subjects in the first cohort will receive 150 mg and 300 mg ascending doses of naringenin and subjects in the second cohort will receive 600 mg and 900 mg ascending doses of naringenin. Each cohort will also have a placebo group.
|
|---|---|---|---|---|---|
|
Measurement of Time to Peak Concentration of Serum Naringenin at 150 and 600 mg Doses
|
3.17 hour
Standard Error 0.74
|
2.41 hour
Standard Error 0.74
|
0 hour
Standard Error 0
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hoursPopulation: Subjects who completed the study. The half-life uses all the pooled data to calculate an estimate of the slope (k) to determine the half-life estimate. We did not calculate the slope of each individual subject.
Blood will be drawn over a period of 24 hours following ingestion of the 150 and 600mg doses of naringenin and serum naringenin concentrations will be measured. The half life of naringenin will be determined.
Outcome measures
| Measure |
150 mg Dose
n=9 Participants
Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 150 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
300 mg Dose
n=9 Participants
Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 300 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
600 mg Dose
n=18 Participants
Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 600 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
900 mg Dose
Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 900 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin.
|
Placebo
Subjects in the first cohort will receive 150 mg and 300 mg ascending doses of naringenin and subjects in the second cohort will receive 600 mg and 900 mg ascending doses of naringenin. Each cohort will also have a placebo group.
|
|---|---|---|---|---|---|
|
Measurement of Half Life of Naringenin at 150 and 600 mg Doses
|
3.0 hour
|
2.65 hour
|
0 hour
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hoursPopulation: Subjects who completed the study
Blood will be drawn over a period of 24 hours following ingestion of the 150 and 600mg doses of naringenin and serum naringenin concentrations will be measured. The apparent oral clearance of naringenin will be determined.
Outcome measures
| Measure |
150 mg Dose
n=9 Participants
Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 150 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
300 mg Dose
n=9 Participants
Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 300 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
600 mg Dose
n=18 Participants
Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 600 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
900 mg Dose
Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 900 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin.
|
Placebo
Subjects in the first cohort will receive 150 mg and 300 mg ascending doses of naringenin and subjects in the second cohort will receive 600 mg and 900 mg ascending doses of naringenin. Each cohort will also have a placebo group.
|
|---|---|---|---|---|---|
|
Measurement of Apparent Oral Clearance of Naringenin at 150 and 600 mg Doses
|
10.21 L/hour
Standard Error 2.34
|
13.7 L/hour
Standard Error 2.34
|
0 L/hour
Standard Error 0
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 and 4 hoursPopulation: Subjects who participated in the study
Blood will be drawn at 0 hours and 4 hours following ingestion of the 300 and 900mg doses of naringenin and serum naringenin concentrations will be measured.
Outcome measures
| Measure |
150 mg Dose
n=9 Participants
Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 150 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
300 mg Dose
n=9 Participants
Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 300 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
600 mg Dose
n=18 Participants
Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 600 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
900 mg Dose
Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 900 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin.
|
Placebo
Subjects in the first cohort will receive 150 mg and 300 mg ascending doses of naringenin and subjects in the second cohort will receive 600 mg and 900 mg ascending doses of naringenin. Each cohort will also have a placebo group.
|
|---|---|---|---|---|---|
|
Measurement of Four-hour Concentration of Serum Naringenin at 300 and 900 mg Doses
|
10.7 uM
Standard Error 5.64
|
43.1 uM
Standard Error 5.3
|
0.3 uM
Standard Error 4.2
|
—
|
—
|
Adverse Events
150 mg Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
300 mg Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
600 mg Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
900 mg Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
150 mg Dose
n=9 participants at risk
Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 150 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
300 mg Dose
n=9 participants at risk
Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 300 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
600 mg Dose
n=9 participants at risk
Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 600 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
|
900 mg Dose
n=9 participants at risk
Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 900 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin.
|
Placebo
n=18 participants at risk
Subjects in the first cohort will receive 150 mg and 300 mg ascending doses of naringenin and subjects in the second cohort will receive 600 mg and 900 mg ascending doses of naringenin. Each cohort will also have a placebo group.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.1%
1/9 • Number of events 1 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/18 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
11.1%
1/9 • Number of events 2 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/18 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
|
Skin and subcutaneous tissue disorders
Acne
|
11.1%
1/9 • Number of events 1 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/18 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
|
Skin and subcutaneous tissue disorders
Cyst on Foot
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/18 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/18 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
|
Nervous system disorders
Drowsiness
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/18 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/18 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
|
Eye disorders
Visual Disturbance
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/9 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
0.00%
0/18 • Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.
The study team employed open-ended and non-leading verbal questioning of the subject as the preferred method to inquire about adverse event occurrence. For example, appropriate questions included: "How are you feeling?", "Have you had any (other) medical problems since your last visit/contact?" The study staff established a diagnosis of the event based on signs, symptoms, and/or other clinical information. Subjects were asked about adverse events at each visit to the clinic for testing.
|
Additional Information
Dr. Candida Rebello
Pennington Biomedical Research Center
Phone: 225-763-3159
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place