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

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Wockhardt

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT02532140
W-5107-101

Details and patient eligibility

About

• 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.

Enrollment

88 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

88 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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