Trial Outcomes & Findings for A Study of Cephalexin Suspension in Healthy Participants (NCT NCT02123459)

NCT ID: NCT02123459

Last Updated: 2015-05-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 28 participants
• Primary outcome timeframe: Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period
• Results posted on: 2015-05-27

Participant Flow

Participant milestones

Measure	Cephalexin Dosing Sequence AB Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).There was an interval of 1 day between doses.	Cephalexin Dosing Sequence BA Each participant was administered Cephalexin B formulation (Treatment B, Test - 1 occasion) and Cephalexin A formulation (Treatment A, Reference - 1 occasion).There was an interval of 1 day between doses.
Period 1 (7 Days) STARTED	14	14
Period 1 (7 Days) COMPLETED	14	14
Period 1 (7 Days) NOT COMPLETED	0	0
Washout Period (1 Day) STARTED	14	14
Washout Period (1 Day) COMPLETED	13	14
Washout Period (1 Day) NOT COMPLETED	1	0
Period 2 (7 Days) STARTED	13	14
Period 2 (7 Days) COMPLETED	13	14
Period 2 (7 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Cephalexin Dosing Sequence AB Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).There was an interval of 1 day between doses.	Cephalexin Dosing Sequence BA Each participant was administered Cephalexin B formulation (Treatment B, Test - 1 occasion) and Cephalexin A formulation (Treatment A, Reference - 1 occasion).There was an interval of 1 day between doses.
Washout Period (1 Day) Adverse Event	1	0

Baseline Characteristics

A Study of Cephalexin Suspension in Healthy Participants

Baseline characteristics by cohort

Measure	Overall Study n=28 Participants Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).
Age, Continuous	30.9 Years STANDARD_DEVIATION 9.57 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Mexico	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period

Population: All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.

Outcome measures

Measure	Cephalexin (Reference) n=27 Participants Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods	Cephalexin (Test) n=27 Participants Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose	29.539 Hours*microgram per milliliter(h*μg/mL) Geometric Coefficient of Variation 22.919	35.857 Hours*microgram per milliliter(h*μg/mL) Geometric Coefficient of Variation 14.452

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period

Population: All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.

Outcome measures

Measure	Cephalexin (Reference) n=27 Participants Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods	Cephalexin (Test) n=27 Participants Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin	10.378 μg/mL Geometric Coefficient of Variation 25.616	12.610 μg/mL Geometric Coefficient of Variation 23.867

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period

Population: All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.

Outcome measures

Measure	Cephalexin (Reference) n=27 Participants Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods	Cephalexin (Test) n=27 Participants Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum	1.500 Hours Standard Deviation 0.881	1.500 Hours Standard Deviation 0.758

Adverse Events

Cephalexin (Reference)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cephalexin (Test)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cephalexin (Reference) n=28 participants at risk Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods Cephalexin: Administered orally	Cephalexin (Test) n=28 participants at risk Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods Cephalexin: Administered orally
Gastrointestinal disorders Nausea	0.00% 0/28	7.1% 2/28 • Number of events 2

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

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

Restriction type: GT60