Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treat… (NCT04874948) | Clinical Trial Compass
CompletedPhase 1
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
Netherlands4 participantsStarted 2021-10-08
Plain-language 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
Who can participate
Age range18 Years – 55 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Sex : male
✓. Age : 18 years to 55 years, inclusive, at screening.
✓. Body mass index (BMI) : 18.0 to 29.0 kg/m2, inclusive, at screening.
✓. Weight : 55 to 90 kg, inclusive, at screening.
✓. Status : healthy subjects.
✓. 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.
✓. All prescribed medication must have been stopped at least 30 days prior to admission to the clinical research center.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Rates and Routes of Excretion
Timeframe: Urine and faeces were collected from the administration of the study medication until cumulative excretion reached 90% of total radioactivity administered. This was achieved by all subjects after 168 hours.
2
Pharmacokinetics of Total Radioactivity in Blood and Plasma (Cmax)
Timeframe: Blood samples for total radioactivity were collected from day 1 until 168 h post dosing
3
Pharmacokinetics of Total Radioactivity in Blood and Plasma (AUC-t)
Timeframe: Blood samples for total radioactivity were collected from day 1 until 168 h post dosing
4
Pharmacokinetics of Total Radioactivity in Blood (T1/2)
Timeframe: Blood samples for total radioactivity were collected from day 1 until 168 h post dosing
5
Pharmacokinetics of Total Radioactivity in Plasma (T1/2)
Timeframe: Blood samples for total radioactivity were collected from day 1 until 168 h post dosing
6
Plasma PK of BTZ-043 and Main Metabolites (Cmax)
Timeframe: Day 1 to Day 3
7
Plasma PK of BTZ-043 and Main Metabolites (AUC-last)
✕. 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.
✕. Irregular defecation pattern (less than once per day on average).
✕. Employee of PRA, Nuvisan, or the Sponsor.
✕. History of relevant drug and/or food allergies.
✕. Using tobacco products within 60 days prior to drug administration.
✕. History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
✕. 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.
8
Plasma PK of BTZ-043 and Main Metabolites (t1/2)
Timeframe: Day 1 to Day 3
9
Urine Concentrations of BTZ-043 and Main Metabolites
Timeframe: Assessed from time of dosing up to 168 h post dose. BTZ-043 and metabolites were excreted fom 0 - 24 h (BTZ-043 and M1) and from 0 - 48 h (M2, M4 total and M10 total).