Trial Outcomes & Findings for Bioavailability, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Participants (NCT NCT02064907)
NCT ID: NCT02064907
Last Updated: 2015-04-14
Results Overview
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
Day 1 predose and up to 24 hours post-dose
Results posted on
2015-04-14
Participant Flow
Participants took part in this study from 31 January 2014 (Date first informed consent signed) to 24 April 2014.
A total of 52 healthy adult participants took part in this study at a single site in the US.
Participant milestones
| Measure |
Dexlansoprazole OD Tablets + Dexlansoprazole Capsules
Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by one dexlansoprazole 60 mg, capsule, orally, once daily for 5 days in Period 2.
|
Dexlansoprazole Capsules + Dexlansoprazole OD Tablets
Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 2.
|
|---|---|---|
|
Period 1
STARTED
|
26
|
26
|
|
Period 1
COMPLETED
|
26
|
26
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
26
|
26
|
|
Period 2
COMPLETED
|
26
|
26
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioavailability, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Participants
Baseline characteristics by cohort
| Measure |
Dexlansoprazole OD Tablets + Dexlansoprazole Capsules
n=26 Participants
Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by one dexlansoprazole 60 mg, capsule, orally, once daily for 5 days in Period 2.
|
Dexlansoprazole Capsules + Dexlansoprazole OD Tablets
n=26 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 2.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.1 Years
STANDARD_DEVIATION 10.11 • n=5 Participants
|
39.1 Years
STANDARD_DEVIATION 10.70 • n=7 Participants
|
37.6 Years
STANDARD_DEVIATION 10.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
19 participants
n=5 Participants
|
13 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or Latino
|
7 participants
n=5 Participants
|
13 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Body Mass Index
|
25.92 kg/m^2
STANDARD_DEVIATION 2.540 • n=5 Participants
|
26.44 kg/m^2
STANDARD_DEVIATION 2.274 • n=7 Participants
|
26.18 kg/m^2
STANDARD_DEVIATION 2.401 • n=5 Participants
|
|
Smoking classification
Never smoked
|
25 participants
n=5 Participants
|
17 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Smoking classification
Current smoker
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Smoking classification
Ex-smoker
|
1 participants
n=5 Participants
|
9 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Alcohol classification
Has never drunk
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Alcohol classification
Current drinker
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Alcohol classification
Ex-drinker
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Caffeine consumption
Yes
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Caffeine consumption
No
|
20 participants
n=5 Participants
|
17 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 predose and up to 24 hours post-dosePopulation: Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
Dexlansoprazole OD Tablets
n=52 Participants
Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
|
Dexlansoprazole Capsules
n=52 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 1.
|
1046.8846 ng/mL
Standard Deviation 496.79560
|
1164.3654 ng/mL
Standard Deviation 667.01483
|
PRIMARY outcome
Timeframe: Day 5 predose and up to 24 hours post-dosePopulation: Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
Dexlansoprazole OD Tablets
n=52 Participants
Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
|
Dexlansoprazole Capsules
n=52 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 5
|
1150.8462 ng/mL
Standard Deviation 668.54581
|
1178.1346 ng/mL
Standard Deviation 570.01221
|
PRIMARY outcome
Timeframe: Day 1 predose and up to 24 hours post-dosePopulation: Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.
AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.
Outcome measures
| Measure |
Dexlansoprazole OD Tablets
n=52 Participants
Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
|
Dexlansoprazole Capsules
n=52 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
|
|---|---|---|
|
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 1
|
5059.5689 ng*hr/mL
Standard Deviation 3689.92045
|
6746.6075 ng*hr/mL
Standard Deviation 5489.74215
|
PRIMARY outcome
Timeframe: Day 5 predose and up to 24 hours post-dosePopulation: Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.
AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.
Outcome measures
| Measure |
Dexlansoprazole OD Tablets
n=52 Participants
Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
|
Dexlansoprazole Capsules
n=52 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
|
|---|---|---|
|
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 5
|
5818.8236 ng*hr/mL
Standard Deviation 5105.56325
|
7184.1729 ng*hr/mL
Standard Deviation 6313.98668
|
PRIMARY outcome
Timeframe: Day 1 predose and up to 24 hours post-dosePopulation: Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.
AUC(0-inf) is a measure of the area under the plasma concentration-time curve from time 0 extrapolated to infinity.
Outcome measures
| Measure |
Dexlansoprazole OD Tablets
n=52 Participants
Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
|
Dexlansoprazole Capsules
n=50 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
|
|---|---|---|
|
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity on Day 1
|
5364.0217 ng*hr/mL
Standard Deviation 4218.37276
|
7155.4994 ng*hr/mL
Standard Deviation 6461.07333
|
PRIMARY outcome
Timeframe: Day 5 predose and up to 24 hours post-dosePopulation: Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.
AUC(0-tau) is a measure of the area under the plasma concentration-time curve from time 0 to time tau over a dosing interval, where tau is the length of the dosing interval (24 hours).
Outcome measures
| Measure |
Dexlansoprazole OD Tablets
n=52 Participants
Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
|
Dexlansoprazole Capsules
n=52 Participants
Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
|
|---|---|---|
|
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval on Day 5
|
5824.7108 ng*hr/mL
Standard Deviation 5105.49002
|
7196.1922 ng*hr/mL
Standard Deviation 6306.70574
|
Adverse Events
Dexlansoprazole OD Tablets
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Dexlansoprazole Capsules
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexlansoprazole OD Tablets
n=52 participants at risk
Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
|
Dexlansoprazole Capsules
n=52 participants at risk
Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.8%
3/52 • From first dose date up to 30 days from the last dose date
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.
|
1.9%
1/52 • From first dose date up to 30 days from the last dose date
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
Flatulence
|
1.9%
1/52 • From first dose date up to 30 days from the last dose date
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.
|
3.8%
2/52 • From first dose date up to 30 days from the last dose date
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
|
9.6%
5/52 • From first dose date up to 30 days from the last dose date
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.
|
11.5%
6/52 • From first dose date up to 30 days from the last dose date
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
|
3.8%
2/52 • From first dose date up to 30 days from the last dose date
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%
0/52 • From first dose date up to 30 days from the last dose date
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
Oropharyngeal Pain
|
1.9%
1/52 • From first dose date up to 30 days from the last dose date
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.
|
3.8%
2/52 • From first dose date up to 30 days from the last dose date
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
Decubitus Ulcer
|
0.00%
0/52 • From first dose date up to 30 days from the last dose date
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.
|
5.8%
3/52 • From first dose date up to 30 days from the last dose date
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
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property
- Publication restrictions are in place
Restriction type: OTHER