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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: WCK 5107 250 mg to 2000 mg; Drug: Placebo; Drug: Cefepime 2000 mg; Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination

• Registration Number: NCT02532140
• Lead Sponsor: Wockhardt

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-20
• Study First Posted: 2015-08-25
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-02
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. Male or female, 18-55 years of age (both inclusive).
2. Have a body mass index of 18-30 kg/m2 (both inclusive) calculated as weight (kg)/height (m2).
3. Medical history without any major pathology/surgery in the last 6 months prior to screening.
4. Resting supine blood pressure of 90-139 (systolic)/40-89 (diastolic) mmHg and a resting pulse rate of 40-100 beats per minute.
5. Calculated creatinine clearance ≥80 mL/min
6. Computerized 12-lead ECG recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the Principal Investigator.
7. Males willing to use double-barrier contraceptive measures and to not donate sperm until 90 days after the follow-up visit.
8. 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.
9. 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.

Exclusion Criteria

1. History/evidence of clinically relevant pathology.
2. History of clinically significant food or drug allergy, including known hypersensitivity to cefepime or any other related drugs.
3. A positive screen result for drugs of abuse/alcohol at admission to the study center.
4. Use of prescription medications (with the exception of oral contraceptives and hormone replacement therapy) including nonsteroidal anti-inflammatory drugs or sucralfate or herbal preparations.
5. Positive screen result for hepatitis B, hepatitis C, or human immunodeficiency virus at screening.
6. 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.
7. History of blood donation of more than 500 mL in the last 2 months prior to screening.
8. Current use or has used tobacco- or nicotine-containing products.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
WCK 5107 2000 mg and Cefepime 2000 mg	WCK 5107 250 mg to 2000 mg	In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments.
WCK 5107	WCK 5107 250 mg to 2000 mg	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)
WCK 5107	Placebo	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)
WCK 5107 1000 mg and Cefepime 2000 mg	WCK 5107 250 mg to 2000 mg	In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments.
WCK 5107 1000 mg and Cefepime 2000 mg	Cefepime 2000 mg	In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments.
WCK 5107 1000 mg and Cefepime 2000 mg	WCK 5107 1000/2000 mg with Cefepime 2000 mg combination	In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments.
WCK 5107 2000 mg and Cefepime 2000 mg	Cefepime 2000 mg	In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments.
WCK 5107 2000 mg and Cefepime 2000 mg	WCK 5107 1000/2000 mg with Cefepime 2000 mg combination	In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments.

Primary Outcome Measures

Name	Time	Method
Safety - number of adverse events .	14 days	To evaluate the safety of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.
Tolerability-measure of laboratory parameters	14 days	To evaluate the tolerability of single intravenous doses of WCK

Secondary Outcome Measures

Name	Time	Method
PK- Cmax	3 days	To evaluate the PK of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.
PK-time to Cmax	3 days	To evaluate the PK of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.
PK-AUC	3 days	To evaluate the PK of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.

Trial Locations

Locations (1)

Quintiles; 🇺🇸 Overland Park, Kansas, United States