Phase I, Open Label,Crossover Food-Effect and Absolute Bioavailability Study of WCK2349 and WCK771 in Healthy Adult Human Volunteers

NCT01875939 | Completed Phase 1

• 1 other identifier: W 771/2349-101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed to ascertain the effect of food on pharmacokinetics of WCK 2349 and determine the absolute bioavailability of WCK 2349 1000 mg (oral, QD dose) with respect to WCK 771 800 mg (intravenous, QD dose). This study would ascertain/confirm the therapeutically equivalent oral and IV doses of WCK 2349 and WCK 771 respectively, and provide guidance in case of switch over therapy (WCK 771, IV to WCK 2349, oral) in future clinical trials in patients.

Conditions

Effect of Food

Keywords

healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Evaluate pharmacokinetics of WCK 2349 (Fed/Fasting)and WCK 771 Fasting

  To compare the pharmacokinetics of WCK 2349 following oral administration of 1000 mg of WCK 2349 (QD, one day) in healthy, adult, human subjects in fed and fasting state To determine the absolute bioavailability of WCK 2349 following oral administration of 1000 mg of WCK 2349 (QD, one day) with respect to intravenous administration of 800 mg of WCK 771 (QD, one day) in healthy adult human subjects in fasting state.Absolute bioavailability (F) of oral WCK 2349 as compared to intravenous WCK 771 following single dose administration in healthy subjects in fasting state will be calculated as follows: F =AUC i.v /AUC oral \*Dose of oral/Dose of IV Summary statistics will be provided for the safety data.

  Approximately 11 days

Secondary Outcomes (1)

• safety of oral WCK 2349 and intravenous WCK 771 in healthy adult human subjects

  Approximately 11 days

Study Arms (2)

Oral WCK 2349 fed/fasting

OTHER

This is a single center, randomized, open label, 2X2 oral IV cross over, food-effect and absolute bioavailability study. The study will be conducted in three parts i.e., Period 1 and Period 2 (foodeffect study) and Period 3 (absolute bioavailability study).

Drug: Oral WCK2349

IV WCK771

OTHER

This is a single center, randomized, open label, 2X2 oral IV cross over, food-effect and absolute bioavailability study. The study will be conducted in three parts i.e., Period 1 and Period 2 (foodeffect study) and Period 3 (absolute bioavailability study).

Drug: IV WCK771

Interventions

Oral WCK2349 DRUG

The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study.

Oral WCK 2349 fed/fasting

IV WCK771 DRUG

The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study.

IV WCK771

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• If female, postmenopausal for at least 1 year,surgically sterile or birth control measures.
• Body Mass Index (BMI) between 18 and 32
• No significant diseases
• No recent history of smoking or alcohol

You may not qualify if:

• Known history of hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs.
• History or evidence of disease or condition which might compromise the haemopoietic, renal, hepatic,endocrine, pulmonary, central nervous, cardiovascular,immunological, dermatological, gastrointestinal or any other body system.
• No receipt of a prescription drug or non-prescription drug .

Sponsors & Collaborators

• Wockhardt: lead

Study Sites (1)

PPD Phase I unit, 7551 Metro Center Drive, Suite 200

Austin, Texas, 78744, United States

Location

Study Officials

• Sabiha A Mondal, MD

  PPD Phase I unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 12, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 22, 2013

Record last verified: 2013-08

Locations

US (1)