Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime

NCT02532140 | Completed Phase 1

• 1 other identifier: W-5107-101
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

• To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Safety - number of adverse events .

  To evaluate the safety of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.

  14 days

• Tolerability-measure of laboratory parameters

  To evaluate the tolerability of single intravenous doses of WCK

  14 days

Secondary Outcomes (3)

• PK- Cmax

  3 days

• PK-AUC

  3 days

• PK-time to Cmax

  3 days

Study Arms (3)

WCK 5107

EXPERIMENTAL

A single administration of the investigational product will be administered intravenously in 7 SAD cohorts at different dose level . The SAD cohorts will enroll 10 subjects ( 8 on active drug and 2 on placebo)

Drug: WCK 5107 250 mg to 2000 mg; Drug: Placebo

WCK 5107 1000 mg and Cefepime 2000 mg

EXPERIMENTAL

In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments.

Drug: WCK 5107 250 mg to 2000 mg; Drug: Cefepime 2000 mg; Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination

WCK 5107 2000 mg and Cefepime 2000 mg

EXPERIMENTAL

In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments.

Drug: WCK 5107 250 mg to 2000 mg; Drug: Cefepime 2000 mg; Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination

Interventions

WCK 5107 250 mg to 2000 mg DRUG

WCK 5107; WCK 5107 1000 mg and Cefepime 2000 mg; WCK 5107 2000 mg and Cefepime 2000 mg

Cefepime 2000 mg DRUG

WCK 5107 1000 mg and Cefepime 2000 mg; WCK 5107 2000 mg and Cefepime 2000 mg

WCK 5107 1000/2000 mg with Cefepime 2000 mg combination DRUG

WCK 5107 1000 mg and Cefepime 2000 mg; WCK 5107 2000 mg and Cefepime 2000 mg

Placebo DRUG

WCK 5107

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, 18-55 years of age (both inclusive).
• Have a body mass index of 18-30 kg/m2 (both inclusive) calculated as weight (kg)/height (m2).
• Medical history without any major pathology/surgery in the last 6 months prior to screening.
• Resting supine blood pressure of 90-139 (systolic)/40-89 (diastolic) mmHg and a resting pulse rate of 40-100 beats per minute.
• Calculated creatinine clearance ≥80 mL/min
• Computerized 12-lead ECG recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the Principal Investigator.
• Males willing to use double-barrier contraceptive measures and to not donate sperm until 90 days after the follow-up visit.
• Females should not be pregnant or breast feeding (pregnancy will be confirmed by a urine pregnancy test at screening with confirmation by a serum pregnancy test at admission) or of non-childbearing potential at screening.
• Females must be either post-menopausal for at least 1 year, surgically sterile (bilateral oophorectomy or hysterectomy), or practicing 1 of the acceptable methods of birth control.

You may not qualify if:

• History/evidence of clinically relevant pathology.
• History of clinically significant food or drug allergy, including known hypersensitivity to cefepime or any other related drugs.
• A positive screen result for drugs of abuse/alcohol at admission to the study center.
• Use of prescription medications (with the exception of oral contraceptives and hormone replacement therapy) including nonsteroidal anti-inflammatory drugs or sucralfate or herbal preparations.
• Positive screen result for hepatitis B, hepatitis C, or human immunodeficiency virus at screening.
• Any strenuous activity within 4 days prior to admission to the study center. Strenuous being defined as any hard labor or exercise outside of a subject's usual behavior.
• History of blood donation of more than 500 mL in the last 2 months prior to screening.
• Current use or has used tobacco- or nicotine-containing products.

Sponsors & Collaborators

• Wockhardt: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

Quintiles

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Interventions

Cefepime

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 25, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 3, 2016

Record last verified: 2016-05

Locations

US (1)