Overview

Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment

Status:
Completed
Trial end date:
2021-10-15
Target enrollment:
0
Participant gender:
Male
Summary
This study is a Phase 1, single-center, open-label study to investigate the absorption, metabolism, and excretion of BTZ-043 after a single oral administration of 500 mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043 in 4 healthy adult male subjects
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Michael Hoelscher
Collaborator:
Leibniz Institute for Natural Product Research and Infection Biology Hans Knöll Institut
Criteria
Inclusion Criteria:

1. Sex : male

2. Age : 18 years to 55 years, inclusive, at screening.

3. Body mass index (BMI) : 18.0 to 29.0 kg/m2, inclusive, at screening.

4. Weight : 55 to 90 kg, inclusive, at screening.

5. Status : healthy subjects.

6. Male subjects, if not surgically sterilized, must agree to use adequate contraception
and not donate sperm from admission to the clinical research center until 90 days
after the follow-up visit. Adequate contraception for the male subject (and his female
partner, if she is of childbearing potential) is defined as using hormonal
contraceptives or an intrauterine device combined with at least 1 of the following
forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence, in
accordance with the lifestyle of the subject, is also acceptable.

7. All prescribed medication must have been stopped at least 30 days prior to admission
to the clinical research center.

8. All over-the-counter medications, vitamin preparations (especially vitamin C), other
food supplements, and herbal medications (eg, St. John's wort) must have been stopped
at least 14 days prior to admission to the clinical research center. An exception is
made for paracetamol, which is allowed up to 48 hours prior to study drug
administration.

9. No vaccination within 14 days prior to study drug administration.

10. Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to
screening and admission to the clinical research center.

11. Ability and willingness to abstain from methylxanthine-containing beverages or food
(coffee, tea, cola, chocolate, and energy drinks), grapefruit (juice), corn (whole
corn kernels and popcorn), cruciferous vegetables, and bitter oranges from 48 hours (2
days) prior to admission to the clinical research center.

12. Good physical and mental health on the basis of medical history, physical examination,
clinical laboratory, ECG, and vital signs, as judged by the Investigator.

13. Willing and able to sign the ICF.

Exclusion Criteria:

1. Participation in another study with a radiation burden of >0.1 mSv and ≤1 mSv in the
period of 1 year prior to screening; a radiation burden of >1.1 mSv and ≤2 mSv in the
period of 2 years prior to screening; a radiation burden of >2.1 mSv and ≤3 mSv in the
period of 3 years prior to screening, etc.

2. Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of
thorax and bony skeleton [excluding spinal column]), or during work within 1 year
prior to drug administration.

3. Irregular defecation pattern (less than once per day on average).

4. Employee of PRA, Nuvisan, or the Sponsor.

5. History of relevant drug and/or food allergies.

6. Using tobacco products within 60 days prior to drug administration.

7. History of alcohol abuse or drug addiction (including soft drugs like cannabis
products).

8. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including
ecstasy], cannabinoids, barbiturates, benzodiazepines, gamma-hydroxybutyric acid,
tricyclic antidepressants, and alcohol) at screening or admission to the clinical
research center.

9. Average intake of more than 24 grams of alcohol per day.

10. Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV)
antibodies, or HIV 1 and 2 antibodies.

11. Participation in a drug study within 30 days prior to drug administration in the
current study. Participation in more than 4 drug studies in the 12 months prior to
drug administration in the current study.

12. Donation or loss of more than 450 mL of blood within 60 days prior to drug
administration. Donation or loss of more than 1.5 liters of blood in the 10 months
prior to drug administration in the current study.

13. Significant and/or acute illness within 5 days prior to drug administration that may
impact safety assessments, in the opinion of the Investigator.

14. Unwillingness to consume the Food and Drug Administration (FDA)-recommended high-fat
breakfast.

15. Unsuitable veins for infusion or blood sampling.

16. Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -1.