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

• Sponsor: Wockhardt (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02532140
• Collaborator: Quintiles, Inc. (Industry)
• Enrollment: 88
• Location: 1
• Arms: 3
• Duration (Months): 4
• Patients Per Site Per Month: 22

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: WCK 5107 250 mg to 2000 mg; Drug: Cefepime 2000 mg; Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Phase I Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime Administered as Single IV Doses in Healthy Human Volunteers
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: WCK 5107 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
Experimental: WCK 5107 1000 mg and Cefepime 2000 mg 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
Experimental: WCK 5107 2000 mg and Cefepime 2000 mg 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

Outcome Measures

Primary Outcome Measures

1. 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.

2. Tolerability-measure of laboratory parameters [14 days]

   To evaluate the tolerability of single intravenous doses of WCK

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quintiles	Overland Park	Kansas	United States	66211

Sponsors and Collaborators

• Wockhardt
• Quintiles, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wockhardt
• ClinicalTrials.gov Identifier: NCT02532140
• Other Study ID Numbers: W-5107-101
• First Posted: Aug 25, 2015
• Last Update Posted: May 3, 2016
• Last Verified: May 1, 2016

• Additional relevant MeSH terms: Cefepime

Study Results

No Results Posted as of May 3, 2016