Trial Outcomes & Findings for Pharmacokinetics of Oseltamivir Carboxylate In Morbidly Obese Subjects (NCT NCT01179919)

NCT ID: NCT01179919

Last Updated: 2017-02-09

Results Overview

AUC is the area under the concentration-time curve. This is measured as concentration in nanograms of oseltamivir carboxylate per milliliter of plasma multiplied by time in hours (hour\*ng/mL)

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: 6 days
• Results posted on: 2017-02-09

Participant Flow

Participant milestones

Measure	Oseltamivir Dosed Group Oseltamivir 75 mg by mouth every 12 hours for 9 doses Oseltamivir: Capsule, 75 mg by mouth for 9 doses
Overall Study STARTED	21
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Oseltamivir Dosed Group Oseltamivir 75 mg by mouth every 12 hours for 9 doses Oseltamivir: Capsule, 75 mg by mouth for 9 doses
Overall Study Protocol Violation	1
Overall Study Adverse Event	1

Baseline Characteristics

Pharmacokinetics of Oseltamivir Carboxylate In Morbidly Obese Subjects

Baseline characteristics by cohort

Measure	Oseltamivir Dosed Group n=21 Participants Oseltamivir 75 mg by mouth every 12 hours for 9 doses Oseltamivir: Capsule, 75 mg by mouth for 9 doses
Age, Continuous	36 years n=5 Participants
Gender Female	17 Participants n=5 Participants
Gender Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Body Mass Index	43.7 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: 6 days

Population: Subjects who received all 9 doses of oseltamivir

AUC is the area under the concentration-time curve. This is measured as concentration in nanograms of oseltamivir carboxylate per milliliter of plasma multiplied by time in hours (hour*ng/mL)

Outcome measures

Measure	Oseltamivir Dosed Group n=19 Participants Oseltamivir 75 mg by mouth every 12 hours for 9 doses Oseltamivir: Capsule, 75 mg by mouth for 9 doses
Steady-State AUC of Oseltamivir Carboxylate	2579 hour*ng/mL Standard Deviation 510

SECONDARY outcome

Timeframe: 6 days

Population: Subjects who received all 9 doses of oseltamivir

Cmax is the maximum concentration and Cmin in the minimum concentration of oseltamivir carboxylate measured in nanogram of oseltamivir carboxylate per milliliter of plasma (ng/mL)

Outcome measures

Measure	Oseltamivir Dosed Group n=19 Participants Oseltamivir 75 mg by mouth every 12 hours for 9 doses Oseltamivir: Capsule, 75 mg by mouth for 9 doses
Steady-State Cmax and Cmin of Oseltamivir Carboxylate Cmax	316 ng/mL Standard Deviation 68.1
Steady-State Cmax and Cmin of Oseltamivir Carboxylate Cmin	113 ng/mL Standard Deviation 37.4

Adverse Events

Oseltamivir Dosed Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Oseltamivir Dosed Group n=21 participants at risk Oseltamivir 75 mg by mouth every 12 hours for 9 doses Oseltamivir: Capsule, 75 mg by mouth for 9 doses
General disorders Anxiety	4.8% 1/21 • Number of events 1 • 6 days

Additional Information

Manjunath Pai

University of Michigan

Phone: 7346473466

Email: amitpai@med.umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place