A study to investigate the effect of enzyme inhibition on the bodily processing of RO6953958 in healthy participants

Phase 1

Completed

• Conditions: on-respiratory sleep disturbances in people with neurodevelopmental disorders (NDDs); Nervous System Diseases

• Registration Number: ISRCTN10164855
• Lead Sponsor: Roche (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-03
• Study Completion: 2022-01-05
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Participants who are healthy as determined by medical evaluation including medical history, surgical history, physical examination, laboratory tests, and cardiac monitoring
2. Body mass index within the range 18 to 32 kg/m² (inclusive).

Exclusion Criteria

1. Any condition or disease detected during the medical interview/physical examination that would render the participant unsuitable for the study, place the participant at undue risk, or interfere with the ability of the participant to complete the study, as determined by the investigator.
2. History or evidence of any medical condition potentially altering the absorption, metabolism, or elimination of drugs. This includes a surgical history of the gastrointestinal tract affecting gastric motility or altering the gastrointestinal tract.
3. History of any clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, or allergic disease; unexplained syncope (within 12 months prior to screening); metabolic disorder; cancer; or cirrhosis.
4. Use of any psychoactive medication, or medications known to have effects on the CNS or blood flow, taken within 30 days prior to the first dosing (or within 5 times the elimination half-life of the medication) prior to the first dosing (whichever is longer).
5. History of convulsions (other than benign febrile convulsions of childhood), including epilepsy, or personal history of significant cerebral trauma or CNS infections (e.g., meningitis).
6. History of clinically significant hypersensitivity (e.g., drugs, excipients) or allergic reactions.
7. Any major illness within 1 month before the screening examination or any febrile illness within 1 week prior to screening and up to the first study drug administration.
8. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
9. Known active infection or any major episode of infection within 4 weeks prior to the start of drug administration.
10. Participants who test positive for SARS-CoV-2 should not be enrolled.
11. Known hypersensitivity to itraconazole or to any of the other excipients, or to any other triazole antifungals.
12. Any other known contraindications to itraconazole as stated in the U.S. Prescribing Information.
13. Have used or intend to use over-the-counter (OTC or prescription medication including herbal medications as described in the list of prohibited medications.
14. Participants likely to need concomitant medication during the study period (including for dental conditions).
15. Positive result on hepatitis B or hepatitis C virus (HCV), presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment. NOTE: Participants with positive hepatitis C antibody test due to prior resolved disease can be enrolled if a confirmatory negative hepatitis C ribonucleic acid test is obtained.
16. A positive pregnancy test (women of childbearing potential only).
17. Positive test for drugs of abuse or alcohol.
18. Show evidence of human immunodeficiency virus (HIV) infection and/or positive test for HIV antibody at screening.
19. Dietary restrictions that would prohibit the consumption of standardized meals.
20. Participants who regularly smoke more than 5 cigarettes daily on average or vape equivalent amounts of nicotine and are unable or unwilling to stop smoking/vaping during the in-house period.
21. Only for the participants who will undergo taste assessment in Period 1: history or evidence of any medical condition that has altered taste sensory perception including age

Study & Design

• Study Type: Interventional
• Study Design: Not specified