Status:
COMPLETED
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Ex-vivo Antitubercular Activity of PBTZ169 Formulation
Lead Sponsor:
Innovative Medicines for Tuberculosis
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
Tuberculosis
Tuberculosis, Pulmonary
Eligibility:
MALE
18-48 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, placebo-controlled, single ascending dose study conducted at one study center in Switzerland. Four (4) panels (A, B, C and D) of 8 male subjects (6 active and 2 pl...
Eligibility Criteria
Inclusion
- Healthy male subjects aged between 18 and 48 years
- Body weight (BW) ranging between 55 and 95 kg, providing body mass index (BMI) is between 18 and 28 kg/m2
- Absence of significant findings in the medical history and physical examination as judged by the Investigator, especially for cardiovascular, pulmonary, haematological and nervous systems
- Absence of significant laboratory abnormalities as judged by the Investigator. Gilbert's syndrome (increased total and unconjugated bilirubin when fasting) will be accepted if mild
- Absence of clinically significant abnormalities on 12-lead ECG
- Negative urine drug screen (amphetamines, benzodiazepines, cannabis, cocaine, opiates)
- Commitment to refrain from travel outside Europe over the whole study duration
- Ability to understand the procedures, agreement to participate and willingness to give written informed consent
- Co-operative attitude and availability for scheduled visits over the entire study period
Exclusion
- History of major cardiovascular, pulmonary, hepatic, immunological, renal, haematological, gastrointestinal, genitourinary, neurological, or rheumatologic disorders
- Active diseases of any type, including inflammatory disorders and infections. Mild acne is permissible providing no systemic or local treatment is provided or planned (except for cleaning lotions)
- History of significant allergy or asthma. Allergic rhinitis or conjunctivitis is acceptable if non-symptomatic when starting the study and if symptoms are not anticipated to occur during the study to a point that would require corticosteroid therapy (e.g. in case of annual use)
- History of cardiovascular dysfunction if considered as clinically relevant (conduction abnormality, arrhythmia, bradycardia, angina pectoris, cardiac hypertrophy unless elicited by training, pulmonary embolism)
- Hypertension defined as supine blood pressure \>150/90 mmHg or recurrent hypotensive events considered as clinically relevant or documented orthostatic hypotension
- Sick sinus syndrome, known long QT syndrome, reproducible observation of QTc ≥ 440 msec or of pronounced sinus bradycardia (\<40 bpm/min)
- Intense sport activities. Moderate sport is acceptable and activities should remain fairly constant throughout the study
- Any clinically significant laboratory values on screening that are not within normal range on single repeat (Gilbert's syndrome acceptable if mild)
- Positive hepatitis B and C antigen screen
- Positive HIV antibody screen or screen not performed
- Any recent acute illness or sequelae thereof which could expose the subject to a higher risk or might confound the results of the study
- Treatment in the previous three months with any drug known to have well-defined potential for toxicity to a major organ
- History of hypersensitivity to any drug if considered as serious
- Use of any medication the week prior to study or as based on the 5 plasma half-life rule and throughout study, including aspirin or other over-the-counter (OTC) preparations. Paracetamol is permissible before and during the study as a rescue medication but only with Investigator's permission
- Participation in a clinical investigation or blood donation of 500 ml within the past 3 months
- History of relevant alcohol or drug abuse
- Usual smoking during the last month before participation in the study. Consumption of ≤ 5 cigarettes/day or equivalent is acceptable providing the subject can totally refrain from smoking from one week before and during the whole study duration
- Usual consumption of a large quantity of coffee, tea, chocolate (more than 4 cups/day) or equivalent (Cola drinks), during the last month before participation in the study
- Current regular (i.e. 3 times per week or more) consumption of large quantities of alcohol or wine (\>0.5 L wine/day) or equivalent (i.e. more than 35 g ethanol per day), during the last month before participation in the study
- Project to conceive a child during the study period (by principle of precaution, while no indication exists for a definite reproductive risk following paternal exposure)
- Psychological status which could impact on the subject's ability to give informed consent
- Any feature of the subject's medical history or present condition which, in the Investigator's opinion, could confound the results of the study, complicate its interpretation, or represent a potential risk for the subject
Key Trial Info
Start Date :
December 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2018
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03423030
Start Date
December 5 2017
End Date
March 28 2018
Last Update
July 13 2018
Active Locations (1)
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1
Division of Clinical Pharmacology, Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011