Completed

CL-003A Phase 1, Randomized, Balanced, Single-Dose, Two-Treatment, Two-Period, Two-Sequence, Crossover, Open-Label Study of the Effect of Food on the Bioavailability and Pharmacokinetics of PA-824 Tablets in Healthy Adult Subjects

What is being tested

PA-824 1000 mg

+ PA-824 1000 mg

Drug

Who is being recruted

Actinomycetales Infections+4

+ Bacterial Infections and Mycoses

+ Bacterial Infections

From 19 to 50 Years

+35 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: March 2007

See protocol details

Summary

Principal SponsorGlobal Alliance for TB Drug Development

Last updated: January 14, 2016

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2007

Actual date on which the first participant was enrolled.

This is a Phase 1, single-center, randomized, balanced, single-dose, two-treatment, two-period, two-sequence, crossover, open-label study to evaluate the effect of food on the pharmacokinetics of PA-824. This study was designed to understand the possible effects of a high-calorie, high-fat meal on PA-824 absorption and pharmacokinetics. The hypothesis to be tested in this study is that the rate and extent of absorption of PA-824, as measured by Tmax, Cmax, AUC(0-t), and AUC(0 inf), are the same after a high-calorie, high-fat meal as compared with after a minimum 10-hour fast.

NCT01828827

Principal SponsorGlobal Alliance for TB Drug Development

Last updated: January 14, 2016

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 19 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Actinomycetales InfectionsBacterial Infections and MycosesBacterial InfectionsInfectionsMycobacterium InfectionsGram-Positive Bacterial InfectionsTuberculosis

Criteria

6 inclusion criteria required to participate

Agree to follow the requirements set forth in the protocol regarding pregnancy controls and donation of sperm, blood, or blood components

Be healthy non-tobacco/nicotine using (6-month minimum) adult subjects, 19 to 50 years of age, inclusive

Be medically healthy subjects with clinically insignificant Screening results (among laboratory profiles, medical histories, ECGs, or physical exam), as deemed by the Principal Investigator

Have a body mass index of 18 to 29

Show More Criteria

29 exclusion criteria prevent from participating

Any clinically significant (as deemed by the Principal Investigator) history, acute illness (resolved within 4 weeks of screening), or presence of cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal (including eating disorders), endocrine, metabolic, immunologic, dermatologic, neurologic, psychological, or psychiatric disease

Any other factor which suggests to the Principal Investigator that the subject should not participate in the study

Any serum creatinine or BUN measure beyond the upper limit of the normal range at Screening or Check-in. Individual values may be discussed with the Sponsor Medical Monitor

Any special dietary changes during the 30 days prior to dosing, as deemed by the Principal Investigator in consultation with the Sponsor Medical Monitor

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Each dose will be 1000 mg PA-824 (5 x 200 mg tablets), and will be administered with 240 mL tap water approximately 30 minutes after a high-calorie, high-fat breakfast provided after a minimum 10-hour overnight fast.

Group II

Experimental

Each dose will be 1000 mg PA-824 (5 x 200 mg tablets), and will be administered with 240 mL tap water after a minimum 10-hour overnight fast.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

MDS Pharma Services

Lincoln, United StatesOpen MDS Pharma Services in Google Maps

CompletedOne Study Center