A Study of Cephalexin in Healthy Participants

NCT02100826 | Completed Phase 1 Results

• 2 other identifiers: 15312A3Q-ME-AFBO
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare two different preparations of an antibiotic called cephalexin to determine if they are essentially the same. The study has two periods. Participants will receive one preparation of cephalexin in each period. At least 7 hours will pass between the study periods. The study is expected to last about 2 days for each participant, not including screening or follow-up.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose

  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

Secondary Outcomes (2)

• Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum

  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

• Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin

  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

Study Arms (2)

Cephalexin (Test)

ACTIVE COMPARATOR

Cephalexin manufactured in Italy by Facta administered once orally in one of two study periods.

Drug: Cephalexin

Cephalexin (Reference)

EXPERIMENTAL

Cephalexin manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.

Drug: Cephalexin

Interventions

Cephalexin DRUG

Administered orally.

Also known as: Keflex®

Cephalexin (Reference); Cephalexin (Test)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participation will be voluntary.
• The body mass index of participants should be between 18-27.
• Participants should have a good health status.
• Limits of variation allowed within normal values at screening will be: blood pressure (seated) up to 139 millimeters of mercury (mm Hg), for systolic, and up to 89 mm Hg for diastolic; heart rate between 60 and 100 beats per minute, and respiratory rate between 14 and 20 breaths per minute.
• Hepatitis B and C and human immunodeficiency virus (HIV) negative.
• Drug abuse and alcohol detection test approximately 12 hours before administering the study medication.
• Serum pregnancy test (beta human chorionic gonadotropin) at screening and urine pregnancy test approximately 12 hours before administering the study medication.

You may not qualify if:

• Participants with any clinically significant abnormality in their vital sign constants recorded at screening.
• Sponsor´s and/or site employees.
• Abnormal 12 lead electrocardiogram (ECG) that in the opinion of the investigator places the participant at an unacceptable risk for study participation, Bazett corrected QR interval (QTcB) \> 470 millisecond (msec) for women and \> 450 msec for men.
• Participants with history of cardiovascular, renal, hepatic, muscular, metabolic, gastrointestinal diseases, including constipation, neurological, endocrine, hematopoietic diseases, or any type of anemia, asthma, mental disease, or other organic abnormalities.
• Participants with a creatinine clearance \< 80 mL/min based on the Cockcroft-Gault equation.
• Participants requiring any medication during the study, apart from the medication which is being studied.
• Participants with history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer.
• Participants who have been exposed to medications known as hepatic enzyme inducers or inhibitors or who have been taking potentially toxic medications within the 30 days prior.
• Participants who have received any medication, including vitamins (with or without medical prescription) or herbal-based remedies 30 days (or 7 half-lives) prior to the beginning of the study.
• Participants who have been hospitalized for any condition within six months to the beginning of the study.
• Participants who have received investigational drugs within the 60 days prior to the study.
• Participants allergic to any medication, food, or substance.
• Participants who require therapy with nephrotoxic drugs.
• Participants who have donated 450 mL of blood or more within the 60 days prior to the beginning of the study.
• Participants with history of drug and alcohol abuse.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.: collaborator

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Mexico City, 14610, Mexico

Location

MeSH Terms

Interventions

Cephalexin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 1, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 27, 2015
• Results First Posted: May 27, 2015

Record last verified: 2015-05

Locations

ME (1)