Trial Outcomes & Findings for PK Study With Pantoprazole in Obese Children and Adolescents (NCT NCT02186652)

Last Updated: 2019-09-17

Results Overview

The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Cmax.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

41 participants

Primary outcome timeframe

pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

Results posted on

2019-09-17

Participant Flow

The first participant for this study began on 8-July-2014. The last participant to complete the study was on 13-September-2015.

Participant milestones

Participant milestones
Measure	Pantoprazole 6-11 Year Old The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping. During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.	Pantoprazole 12-17 Year Old The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping. During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.
Overall Study STARTED	19	22
Overall Study COMPLETED	17	22
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Pantoprazole 6-11 Year Old The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping. During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.	Pantoprazole 12-17 Year Old The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping. During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

PK Study With Pantoprazole in Obese Children and Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pantoprazole 6-11 Year Old n=19 Participants The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping. During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.	Pantoprazole 12-17 Year Old n=22 Participants The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping. During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.	Total n=41 Participants Total of all reporting groups
Age, Continuous	10 years STANDARD_DEVIATION 2 • n=5 Participants	15 years STANDARD_DEVIATION 2 • n=7 Participants	12 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 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
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	22 participants n=7 Participants	41 participants n=5 Participants
Weight	60.5 kg STANDARD_DEVIATION 23.7 • n=5 Participants	97.9 kg STANDARD_DEVIATION 19.6 • n=7 Participants	80.6 kg STANDARD_DEVIATION 28.5 • n=5 Participants
Weight Percentile	96.8 percentile STANDARD_DEVIATION 3.6 • n=5 Participants	97.9 percentile STANDARD_DEVIATION 3.4 • n=7 Participants	97.4 percentile STANDARD_DEVIATION 3.5 • n=5 Participants
Height	144.4 cm STANDARD_DEVIATION 13.9 • n=5 Participants	166.6 cm STANDARD_DEVIATION 7.4 • n=7 Participants	156.3 cm STANDARD_DEVIATION 15.6 • n=5 Participants
Height Percentile	65.3 percentile STANDARD_DEVIATION 28.9 • n=5 Participants	60.9 percentile STANDARD_DEVIATION 29.7 • n=7 Participants	62.9 percentile STANDARD_DEVIATION 29.1 • n=5 Participants
BMI	28.0 kg/m^2 STANDARD_DEVIATION 5.8 • n=5 Participants	35.0 kg/m^2 STANDARD_DEVIATION 5.0 • n=7 Participants	31.7 kg/m^2 STANDARD_DEVIATION 6.4 • n=5 Participants
BMI Percentile	98 percentile STANDARD_DEVIATION 1 • n=5 Participants	98 percentile STANDARD_DEVIATION 1 • n=7 Participants	98 percentile STANDARD_DEVIATION 1 • n=5 Participants

PRIMARY outcome

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

Population: All participants with evaluable data.

Outcome measures

Outcome measures
Measure	Pantoprazole 6-11 Year Old n=18 Participants same as the participant flow wording.	Pantoprazole 12-17 Year Old n=21 Participants same as participant flow wording.	1/1 Allele or 1/17 Allele Extensive Metabolizer
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax).	4.27 mcg/ml Standard Deviation 1.43	4.1 mcg/ml Standard Deviation 1.18	—

PRIMARY outcome

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

Population: All participants with evaluable data.

Outcome measures

Outcome measures
Measure	Pantoprazole 6-11 Year Old n=18 Participants same as the participant flow wording.	Pantoprazole 12-17 Year Old n=21 Participants same as participant flow wording.	1/1 Allele or 1/17 Allele Extensive Metabolizer
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Tmax).	2.3 hours Interval 1.5 to 3.0	2.5 hours Interval 1.5 to 8.0	—

PRIMARY outcome

Timeframe: Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing

Population: All participants with evaluable data

Total number of fresh plasma samples (all participants)

Outcome measures

Outcome measures
Measure	Pantoprazole 6-11 Year Old n=203 Plasma samples same as the participant flow wording.	Pantoprazole 12-17 Year Old n=235 Plasma samples same as participant flow wording.	1/1 Allele or 1/17 Allele Extensive Metabolizer
PK Sampling	11 Plasma samples Standard Deviation 2	11 Plasma samples Standard Deviation 2	—

PRIMARY outcome

Timeframe: Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing

Population: All participants with evaluable data

Concentration of panto in plasma and concentration of panto sulfone in plasma

Outcome measures

Outcome measures
Measure	Pantoprazole 6-11 Year Old n=203 plasma samples same as the participant flow wording.	Pantoprazole 12-17 Year Old n=235 plasma samples same as participant flow wording.	1/1 Allele or 1/17 Allele Extensive Metabolizer
Drug Concentration in Plasma Samples Pantoprazole	1558 ng/ml Standard Deviation 1584.6	1626.1 ng/ml Standard Deviation 1545.2	—
Drug Concentration in Plasma Samples Pantoprazole Sulfone	94.7 ng/ml Standard Deviation 49.1	88.7 ng/ml Standard Deviation 36.8	—

PRIMARY outcome

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

Population: All participants with evaluable data.

Outcome measures

Outcome measures
Measure	Pantoprazole 6-11 Year Old n=18 Participants same as the participant flow wording.	Pantoprazole 12-17 Year Old n=21 Participants same as participant flow wording.	1/1 Allele or 1/17 Allele Extensive Metabolizer
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).	8.87 mcg*h/mL Standard Deviation 4.00	11.56 mcg*h/mL Standard Deviation 4.81	—

PRIMARY outcome

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

Population: All participants with evaluable data.

Outcome measures

Outcome measures
Measure	Pantoprazole 6-11 Year Old n=18 Participants same as the participant flow wording.	Pantoprazole 12-17 Year Old n=21 Participants same as participant flow wording.	1/1 Allele or 1/17 Allele Extensive Metabolizer
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).	5.73 mcg*h/mL Standard Deviation 2.48	6.82 mcg*h/mL Standard Deviation 2.70	—

PRIMARY outcome

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

Population: All participants with evaluable data.

Outcome measures

Outcome measures
Measure	Pantoprazole 6-11 Year Old n=18 Participants same as the participant flow wording.	Pantoprazole 12-17 Year Old n=21 Participants same as participant flow wording.	1/1 Allele or 1/17 Allele Extensive Metabolizer
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (CL/F).	0.14 l/h/kg TBW Standard Deviation 0.07	0.10 l/h/kg TBW Standard Deviation 0.04	—

PRIMARY outcome

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

Population: All participants with evaluable data.

Outcome measures

Outcome measures
Measure	Pantoprazole 6-11 Year Old n=18 Participants same as the participant flow wording.	Pantoprazole 12-17 Year Old n=21 Participants same as participant flow wording.	1/1 Allele or 1/17 Allele Extensive Metabolizer
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).	0.16 L/kg TBW Standard Deviation 0.05	0.14 L/kg TBW Standard Deviation 0.04	—

PRIMARY outcome

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

Population: All participants with evaluable data.

Outcome measures

Outcome measures
Measure	Pantoprazole 6-11 Year Old n=18 Participants same as the participant flow wording.	Pantoprazole 12-17 Year Old n=21 Participants same as participant flow wording.	1/1 Allele or 1/17 Allele Extensive Metabolizer
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).	0.25 L/kg LBW Standard Deviation 0.09	0.25 L/kg LBW Standard Deviation 0.07	—

SECONDARY outcome

Timeframe: 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose

Population: Total analyzed #participants is 38. Total #participants in age groups is 37 excluding one poor-metabolizer. Poor metabolizer is defined as a participant who had \*2/\*2 alleles; intermediate metabolizer is defined as a participant who had \*1/\*2 or \*2/\*17 alleles; extensive metabolizer is defined as a participant who had \*1/\*1 or \*1/\*17 alleles.

To examine the association of CYP2C19 genotype and its association with CYP2C19 phenotypes. To characterize the ability of the CYP2C19 genotype to predict pantoprazole plasma clearance, a correlation with CYP2C19 phenotype was explored using both standard linear and nonlinear regression techniques and their respective tests for significance and goodness of fit. In addition, the impact of all covariates on pantoprazole systemic exposure and apparent plasma clearance (e.g., demographic determinants of extent of obesity such as the waist:hip ratio, CYP2C19 genotype, BMI, and REE) was explored using validated population-based PK methods (NONMEM).

Outcome measures

Outcome measures
Measure	Pantoprazole 6-11 Year Old n=1 Participants same as the participant flow wording.	Pantoprazole 12-17 Year Old n=16 Participants same as participant flow wording.	1/1 Allele or 1/17 Allele n=21 Participants Extensive Metabolizer
The CYP2C19 Genotype and Its Association With CYP2C19 Phenotype	1.29 L/h 1 participant only	6.00 L/h Interval 2.64 to 11.62	8.97 L/h Interval 4.66 to 16.71

Adverse Events

6-11 Year Old Adverse Events

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

12-17 Year Old Adverse Events

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	6-11 Year Old Adverse Events n=19 participants at risk Study participants were selected from obese children and adolescents ranging in age from 6 17 years (inclusive) and seen in the outpatient clinic for the diagnosis or treatment of GERD. The target enrollment was 40 participants (20 participants 6-11 years of age and up to 20 participants 12 17 years of age). Potential study participants could come from any outpatient clinical setting within participating institutions where children with GERD were seen for evaluation and/or treatment.	12-17 Year Old Adverse Events n=22 participants at risk Study participants were selected from obese children and adolescents ranging in age from 6 17 years (inclusive) and seen in the outpatient clinic for the diagnosis or treatment of GERD. The target enrollment was 40 participants (20 participants 6-11 years of age and up to 20 participants 12 17 years of age). Potential study participants could come from any outpatient clinical setting within participating institutions where children with GERD were seen for evaluation and/or treatment.
Gastrointestinal disorders Vomiting	0.00% 0/19 • Adverse events were followed up to 10 days post study dose. An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)	4.5% 1/22 • Number of events 1 • Adverse events were followed up to 10 days post study dose. An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)
General disorders Pyrexia	0.00% 0/19 • Adverse events were followed up to 10 days post study dose. An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)	4.5% 1/22 • Number of events 1 • Adverse events were followed up to 10 days post study dose. An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)
Infections and infestations Urinary Tract Infection	0.00% 0/19 • Adverse events were followed up to 10 days post study dose. An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)	4.5% 1/22 • Number of events 1 • Adverse events were followed up to 10 days post study dose. An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)
Injury, poisoning and procedural complications Laceration	0.00% 0/19 • Adverse events were followed up to 10 days post study dose. An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)	4.5% 1/22 • Number of events 1 • Adverse events were followed up to 10 days post study dose. An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)
Nervous system disorders Headache	5.3% 1/19 • Number of events 1 • Adverse events were followed up to 10 days post study dose. An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)	4.5% 1/22 • Number of events 1 • Adverse events were followed up to 10 days post study dose. An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)
Renal and urinary disorders nephrolithiasis	0.00% 0/19 • Adverse events were followed up to 10 days post study dose. An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)	4.5% 1/22 • Number of events 1 • Adverse events were followed up to 10 days post study dose. An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/19 • Adverse events were followed up to 10 days post study dose. An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)	4.5% 1/22 • Number of events 1 • Adverse events were followed up to 10 days post study dose. An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/19 • Adverse events were followed up to 10 days post study dose. An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)	4.5% 1/22 • Number of events 1 • Adverse events were followed up to 10 days post study dose. An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)

Additional Information

Chad Livingston

Duke Clinical Research Institute

Phone: 919-668-1935

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place