Study to Evaluate the Safety, Tolerability, and Pharmacok... | NCT02532140

Status Module

Name	Class
Quintiles, Inc.	INDUSTRY

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
PK- Cmax	To evaluate the PK of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.	3 days
PK-AUC	To evaluate the PK of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

ID	Term
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930	Organic Chemicals
D013843	Thiazines
D013457	Sulfur Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds