Tuberculosis
Conditions
Interventions
Delamanid whole tablet formulation
Delamanid dispersed tablet formulation
Sponsors
Stellenbosch University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Volunteers are required to meet all of the following inclusion criteria in order to be considered eligible: 1. Provide written, informed consent prior to all trial-related procedures, including for HIV testing; 2. Able and willing to comply with the requirements of the protocol, including attendance of study visits and performance of study procedures; 3. Male or female, aged between 18 and 55 years, both inclusive; 4. Body weight (in light clothing and with no shoes) of = 40kg and = 90 kg; 5. Be of non-childbearing potential or agree to use effective methods of birth control throughout participation in the study until at least 3 months after last dose of study therapy: Non-childbearing potential: (a) Female participant/sexual partner - bilateral oophorectomy, bilateral tubal ligation at least 12 months prior to study participation, and/or hysterectomy or has been postmenopausal with a history of no menses for at least 12 consecutive months; or (b) Male participant/sexual partner - vasectomised or has had a bilateral orchidectomy minimally three months prior to screening; (c) Male participant with pregnant female partner, for the duration of the study period, and who does not have any other sexual partners; Effective birth control methods: (a) Participant - not heterosexually active or practicing sexual abstinence; or (b) Double barrier method which can include a male condom, diaphragm, cervical cap, or female condom (male and female condoms should not be used together); or (b) Barrier method combined with hormone-based contraceptives or an intra-uterine device for the female partner.
Exclusion criteria
Exclusion criteria: Volunteers will be excluded from participation in the study if they meet any of the following criteria: 1. Evidence of clinically significant (as judged by the Investigator) metabolic, cardiovascular, gastrointestinal, musculoskeletal, pulmonary, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities that might compromise the safety of the volunteer or which might interfere with study conduct; 2. Presence of any diseases or conditions in which use of the study treatment is contra-indicated; 3. Known hypersensitivity or intolerance to delamanid; 4. Evidence or symptoms of active TB; 5. Recent (within the last 12 months) household contact with an infectious TB case; 6. Volunteers who are scheduled to receive any other investigational drug during the course of the study; 7. Volunteers with HIV infection; 6. Body mass index (BMI) = 30; 8. A female volunteer who is pregnant, breastfeeding, or planning to conceive a child within the anticipated period of participating in the trial; 9. Volunteers with the following laboratory abnormalities at screening as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, 27 November 2017: a. Haemoglobin =8.0 g/dL; b. Platelets 1.5 x ULN; e. Albumin 450 milliseconds (ms) (QT interval, corrected using Fredericia correction); b. Prolongation of the QRS complex over 120 milliseconds; c. Atrioventricular (AV) block with PR interval > 200 milliseconds. 13. Use of any prohibited medication in the previous 30 days prior to study treatment initiation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the relative bioavailability of delamanid in 3 separate doses of 25mg, 50mg and 100mg, given to healthy adult male and female volunteers orally after dispersing in water, compared to the original tablet form under fed conditions | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine if any dose adjustments are needed when using dispersed compared to whole tablets, and if so how dose adjustments should be done 2. To characterize the short term safety, palatability and acceptability of dispersed and whole tablets of delamanid in 24 healthy male and female volunteers 3. To evaluate the difference in rate of absorption between dispersed tablets compared whole tablets 4. To evaluate the difference in the variability in bioavailability and rate of absorption between crushed and dispersed tablets compared to whole tablets | — |
Countries
South Africa
Contacts
Public ContactVeronique De Jager
Principal Investigator
Outcome results
None listed