Trial Outcomes & Findings for Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux Disease (NCT NCT01045096)

NCT ID: NCT01045096

Last Updated: 2012-04-05

Results Overview

Time to reach the maximum plasma concentration (Cmax) of Dexlansoprazole, equal to time (hours) to Cmax, as observed on Day 7. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

36 participants

Primary outcome timeframe

Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

Results posted on

2012-04-05

Participant Flow

Participants took part in this study at 3 investigative sites in the United States from 04 March 2010 to 09 February 2011.

36 participants with gastroesophageal reflux disease were assigned to 1 of 3 once daily (QD) treatment regimens (15 mg, 30 mg or 60 mg dexlansoprazole) based on baseline body weight.

Participant milestones

Participant milestones
Measure	Dexlansoprazole 15 mg QD Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.	Dexlansoprazole 30 mg QD Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days	Dexlansoprazole 60 mg QD Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
Overall Study STARTED	12	12	12
Overall Study Pharmacokinetic Set	9	11	11
Overall Study COMPLETED	9	12	12
Overall Study NOT COMPLETED	3	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Dexlansoprazole 15 mg QD Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.	Dexlansoprazole 30 mg QD Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days	Dexlansoprazole 60 mg QD Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
Overall Study Withdrawal by Subject	2	0	0
Overall Study Other	1	0	0

Baseline Characteristics

Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexlansoprazole 15 mg QD n=12 Participants Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.	Dexlansoprazole 30 mg QD n=12 Participants Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days	Dexlansoprazole 60 mg QD n=12 Participants Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days	Total n=36 Participants Total of all reporting groups
Age Continuous	3.3 years STANDARD_DEVIATION 1.97 • n=5 Participants	7.8 years STANDARD_DEVIATION 2.89 • n=7 Participants	10.2 years STANDARD_DEVIATION 0.72 • n=5 Participants	7.1 years STANDARD_DEVIATION 3.50 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	24 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	6 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	22 participants n=4 Participants
Race/Ethnicity, Customized Non-Hispanic or Latino	6 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	14 participants n=4 Participants
Race/Ethnicity, Customized Black or African American	2 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Race/Ethnicity, Customized White	8 participants n=5 Participants	12 participants n=7 Participants	12 participants n=5 Participants	32 participants n=4 Participants
Race/Ethnicity, Customized Multiracial	2 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	12 participants n=5 Participants	36 participants n=4 Participants
Mean height	92.5 cm STANDARD_DEVIATION 24.16 • n=5 Participants	131.9 cm STANDARD_DEVIATION 18.80 • n=7 Participants	146.3 cm STANDARD_DEVIATION 8.73 • n=5 Participants	123.6 cm STANDARD_DEVIATION 29.17 • n=4 Participants
Overall Mean Weight	15.7 kg STANDARD_DEVIATION 5.43 • n=5 Participants	29.7 kg STANDARD_DEVIATION 11.86 • n=7 Participants	41.0 kg STANDARD_DEVIATION 8.50 • n=5 Participants	28.8 kg STANDARD_DEVIATION 13.64 • n=4 Participants
Number of Participants per Weight Group 8.6 kg - < 12.7 kg	5 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	5 participants n=4 Participants
Number of Participants per Weight Group 12.7 kg - < 25.4 kg	7 participants n=5 Participants	6 participants n=7 Participants	0 participants n=5 Participants	13 participants n=4 Participants
Number of Participants per Weight Group ≥ 25.4 kg	0 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants	18 participants n=4 Participants
Mean Weight per Weight Group 8.6 kg - < 12.7 kg	11.1 kg STANDARD_DEVIATION 1.05 • n=5 Participants	NA kg STANDARD_DEVIATION NA • n=7 Participants	NA kg STANDARD_DEVIATION NA • n=5 Participants	11.1 kg STANDARD_DEVIATION 1.05 • n=4 Participants
Mean Weight per Weight Group 12.7 kg - < 25.4 kg	19.0 kg STANDARD_DEVIATION 4.76 • n=5 Participants	20.3 kg STANDARD_DEVIATION 3.67 • n=7 Participants	NA kg STANDARD_DEVIATION NA • n=5 Participants	19.6 kg STANDARD_DEVIATION 4.17 • n=4 Participants
Mean Weight per Weight Group ≥ 25.4 kg	NA kg STANDARD_DEVIATION NA • n=5 Participants	39.1 kg STANDARD_DEVIATION 9.19 • n=7 Participants	41.0 kg STANDARD_DEVIATION 8.50 • n=5 Participants	40.3 kg STANDARD_DEVIATION 8.51 • n=4 Participants
Body Mass Index (BMI)	22.3 kg/m^2 STANDARD_DEVIATION 20.08 • n=5 Participants	16.4 kg/m^2 STANDARD_DEVIATION 3.09 • n=7 Participants	19.0 kg/m^2 STANDARD_DEVIATION 2.56 • n=5 Participants	19.2 kg/m^2 STANDARD_DEVIATION 11.73 • n=4 Participants

PRIMARY outcome

Timeframe: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

Population: Pharmacokinetic (PK) set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.

Time to reach the maximum plasma concentration (Cmax) of Dexlansoprazole, equal to time (hours) to Cmax, as observed on Day 7. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.

Outcome measures

Outcome measures
Measure	Dexlansoprazole 15 mg QD n=9 Participants Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.	Dexlansoprazole 30 mg QD n=11 Participants Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days	Dexlansoprazole 60 mg QD n=11 Participants Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
Time to Reach the Peak Plasma Concentration (Tmax)	4.4 hours Standard Deviation 3.18	4.1 hours Standard Deviation 2.34	4.1 hours Standard Deviation 3.59

PRIMARY outcome

Timeframe: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

Population: Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.

Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.

Outcome measures

Outcome measures
Measure	Dexlansoprazole 15 mg QD n=9 Participants Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.	Dexlansoprazole 30 mg QD n=11 Participants Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days	Dexlansoprazole 60 mg QD n=11 Participants Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
The Peak Plasma Concentration (Cmax)	559 ng/mL Standard Deviation 225.3	1005 ng/mL Standard Deviation 748.1	964 ng/mL Standard Deviation 519.0

PRIMARY outcome

Timeframe: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

Population: Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.

AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.

Outcome measures

Outcome measures
Measure	Dexlansoprazole 15 mg QD n=9 Participants Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.	Dexlansoprazole 30 mg QD n=11 Participants Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days	Dexlansoprazole 60 mg QD n=11 Participants Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc))	1914 ng*hr/mL Standard Deviation 631.8	2892 ng*hr/mL Standard Deviation 1668.6	3747 ng*hr/mL Standard Deviation 2795.6

PRIMARY outcome

Timeframe: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

Population: Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.

AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.

Outcome measures

Outcome measures
Measure	Dexlansoprazole 15 mg QD n=6 Participants Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.	Dexlansoprazole 30 mg QD n=8 Participants Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days	Dexlansoprazole 60 mg QD n=6 Participants Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24))	2149 ng*hr/mL Standard Deviation 563.7	2628 ng*hr/mL Standard Deviation 1383.2	3330 ng*hr/mL Standard Deviation 1883.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

Population: Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.

Maximum observed plasma concentration (the peak plasma concentration of a drug after administration), normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.

Outcome measures

Outcome measures
Measure	Dexlansoprazole 15 mg QD n=9 Participants Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.	Dexlansoprazole 30 mg QD n=11 Participants Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days	Dexlansoprazole 60 mg QD n=11 Participants Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
Dose-normalized Peak Plasma Concentration (Cmax/Dose)	37.3 ng/mL/mg Standard Deviation 15.02	33.5 ng/mL/mg Standard Deviation 24.94	16.1 ng/mL/mg Standard Deviation 8.65

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

Population: Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.

AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule, and normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.

Outcome measures

Outcome measures
Measure	Dexlansoprazole 15 mg QD n=9 Participants Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.	Dexlansoprazole 30 mg QD n=11 Participants Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days	Dexlansoprazole 60 mg QD n=11 Participants Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc)/Dose)	128 ng*hr/mL/mg Standard Deviation 42.1	96 ng*hr/mL/mg Standard Deviation 55.6	62 ng*hr/mL/mg Standard Deviation 46.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

Population: Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.

AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule and normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.

Outcome measures

Outcome measures
Measure	Dexlansoprazole 15 mg QD n=6 Participants Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.	Dexlansoprazole 30 mg QD n=8 Participants Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days	Dexlansoprazole 60 mg QD n=6 Participants Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)/Dose)	143.2 ng*hr/mL/mg Standard Deviation 37.58	87.6 ng*hr/mL/mg Standard Deviation 46.11	55.5 ng*hr/mL/mg Standard Deviation 31.39

Adverse Events

Dexlansoprazole 15 mg QD

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Dexlansoprazole 30 mg QD

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Dexlansoprazole 60 mg QD

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dexlansoprazole 15 mg QD n=12 participants at risk Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.	Dexlansoprazole 30 mg QD n=12 participants at risk Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days	Dexlansoprazole 60 mg QD n=12 participants at risk Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
Gastrointestinal disorders Vomiting	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Other adverse events
Measure	Dexlansoprazole 15 mg QD n=12 participants at risk Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.	Dexlansoprazole 30 mg QD n=12 participants at risk Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days	Dexlansoprazole 60 mg QD n=12 participants at risk Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Vomiting	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Haematochezia	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Irritability	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Herpes zoster	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Decreased appetite	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dizziness	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Presyncope	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Sinus congestion	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Rash	8.3% 1/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Sr. VP, Clinical Science

Takeda Global Research and Development Center, Inc.

Phone: 800-778-2860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights therefrom or any data, information or materials obtained or generated in the performance of it's obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
Publication restrictions are in place

Restriction type: OTHER