Chagas disease, Visceral Leishmaniasis and Cutaneous Leishmaniasis. Infections and Infestations
Conditions
Interventions
This is a single part study. It is planned to enrol 8 healthy men. On Day 1, participants will take a single oral dose of 300 mg [14C]LXE408 Oral Suspension containing not more than [NMT] 44.8 kBq rad
Sponsors
Novartis Pharmaceuticals UK Limited
Eligibility
Sex/Gender
Male
Age
30 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Healthy males aged 30 to 55 years inclusive at screening. 3. In good health as determined by no clinically significant findings from medical history, physical examination, vital signs, ECG, and laboratory tests at screening. 4. At screening, baseline (Day -1) and pre-dose, vital signs after resting in supine position for 5 minutes must be within the following ranges: 4.1. Body temperature from 35.0 to 37.5°c, inclusive 4.2. Systolic blood pressure (sbp) from 90 to 140 mm hg inclusive. 4.3. Diastolic blood pressure (dbp) from 50 to 90 mm hg inclusive. 4.4. Pulse rate from 45 to 100 bpm, inclusive 5. Weigh at least 50 kg with a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 at screening. 6. Participants must demonstrate their ability to swallow an empty size 00 capsule. 7. Participants agree to be available for the entire duration of the study and to be able to adhere to the study restrictions and visit schedule. 8. Able to communicate well with the Investigator and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Use of another investigational drug within 5 half-lives or within 90 days/until the expected pharmacodynamic effect has returned to baseline prior to dosing, whichever is longer. 2. Participants who are, or are immediate family members of, a study site or sponsor employee. 3. History of hypersensitivity to the investigational compound/compound class/radioactive substances or excipients being used in this study. 4. Participant has, in the opinion of the Investigator, a known relevant allergy (not including mild seasonal hay fever and/or conjunctivitis or low-grade food intolerances), a preexisting history of a relevant allergic condition, or a predisposition for an allergic reaction. 5. Participants who do not have suitable veins for multiple venipunctures/cannulations as assessed by the investigator or delegate at Screening. 6. History or presence of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 7. History of drug abuse or unhealthy alcohol use within the 12 months prior to dosing. Regular alcohol consumption > 21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type). 8. Current users of any nicotine-containing products including but not limited to cigarettes, cigars, chewing tobacco, vaporizers, e-cigarettes and nicotine replacement products and those who have used these products or smoked within the last 3 months. 9. A confirmed breath carbon monoxide (CO) reading of > 10 ppm at screening or baseline. 10. Confirmed positive drugs of abuse test result at screening or baseline. 11. A confirmed positive alcohol breath test at screening or baseline. 12. Use of any prescription drugs, over-the-counter medications, herbal supplements, or cannabis/marijuana/cannabidiol-containing products, within 4 weeks prior to dosing. If needed, paracetamol/acetaminophen up to 2 g per 24 hours is acceptable, but must be documented in the Concomitant medications / Significant non-drug therapies page of the CRF. Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no PD activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardize the safety of the trial participant; and if the use of medication is not considered to interfere with the objectives of the study. 13. Use of antiacid drugs within 4 weeks prior to dosing. 14. Use of any dietary supplements (vitamins included) within 2 weeks prior to dosing. 15. Absence of regular defecation pattern (participants with an average defecation frequency of less than once per 2 days or chronic diarrhea). 16. Any surgical or medical condition that might significantly alter the ADME properties of drugs, or that may jeopardize the participant in case of participation in the study. The investigator should make this determination in consideration of the participant’s medical history and/or clinical or laboratory evidence of any of the following: 16.1. Inflammatory bowel disease, peptic ulcers, gastrointestinal (GI) disease including rectal bleeding. 16.2. Major GI tract surgery such as gastrectomy, gastroenterostomy, bowel resection or splenectomy. 16.3. Pancreatic injury or pancreatitis. 16.4. Evidence of urinary obstruction or difficulty in
Countries
England, United Kingdom
Contacts
Public ContactNovartis Study Director
Outcome results
None listed