Tuberculosis Clinical Trial
Official title:
A Phase 1, Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and the Induction Potential of TBAJ-876 on CYP3A4 and P-glycoprotein and the Inhibition Potential of TBAJ-876 on P-glycoprotein in Healthy Adult Subjects
Verified date | May 2023 |
Source | Global Alliance for TB Drug Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A Phase 1, Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and the Induction Potential of TBAJ-876 on CYP3A4 and P-glycoprotein and the Inhibition Potential of TBAJ-876 on P-glycoprotein in Healthy Adult Subjects
Status | Completed |
Enrollment | 28 |
Est. completion date | August 28, 2022 |
Est. primary completion date | August 28, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Key Inclusion Criteria: - Is a healthy adult male or female, 18 to 55 years of age (inclusive) at the time of screening. - Has a body mass index (BMI) =18.5 and =32.0 (kg/m2) and a body weight of no less than 50.0 kg at the time of screening and check-in. - Is medically healthy with no clinically significant screening results (e.g., laboratory profiles normal or up to Grade 1 per Division of Microbiology and Infectious Diseases (DMID) Toxicity Tables), as deemed by the Investigator. - Has not used tobacco- or nicotine-containing products (including smoking cessation products), for a minimum of 6 months before dosing. - Is willing and able to consume the entire high-calorie, high-fat breakfast meal in the timeframe required. Key Exclusion Criteria: - History or presence of significant cardiovascular abnormalities, heart murmur, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease as determined by the Investigator to be clinically relevant. - Any musculoskeletal abnormality (severe tenderness with marked impairment of activity) or musculoskeletal toxicity (frank necrosis). - Positive results at screening for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV). - Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) results within 6 days prior to Day 1. - Current or history of prolonged QT syndrome. - Family history of Long-QT Syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death (such as known coronary artery disease, congestive heart failure or terminal cancer). - Use of any drugs or substances known to be inducers of CYP enzymes and/or P-gp, including St. John's Wort, within 30 days prior to the first dose of study drug. - Is lactose intolerant. - History or presence of allergic, or adverse response to midazolam, digoxin, dolutegravir, tenofovir, lamivudine or any related drugs. |
Country | Name | City | State |
---|---|---|---|
United States | TKL Research, Inc. | Fair Lawn | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Global Alliance for TB Drug Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TBAJ-876 effect on the pharmacokinetics of the CYP-3A4 substrate midazolam and the inhibition potential of TBAJ-876 on P-gp in healthy adult subjects | Geometric mean ratio of midazolam's area under the (plasma concentration vs. time) curve when co-administered with TBAJ-876 versus when administered alone, and similarly for the maximum concentration. Inference will be based on analysis of variance applied to log-transformed parameters. | Day 1: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours; Day 20: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours | |
Primary | TBAJ-876 effect on the pharmacokinetics of the P-gp substrate digoxin | Geometric mean ratio of digoxin's area under the (plasma concentration vs. time) curve when co-administered with TBAJ-876 versus when administered alone, and similarly for the maximum concentration. Inference will be based on analysis of variance applied to log-transformed parameters. | Day 2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours; Day 21: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours | |
Secondary | Number of Participants with Treatment-Related Adverse Events in Group 1 Population | Subjects will be monitored for any adverse events from the signing of the consent form until the end-of-study visit. The Investigator or a Sub-Investigator will assess its relationship to the study drug. | from date of the start of treatment to the end of study at 25 days | |
Secondary | Number of Participants with Treatment-Related Adverse Events in Group 2 Population | Subjects will be monitored for any adverse events from the signing of the consent form until the end-of-study visit. The Investigator or a Sub-Investigator will assess its relationship to the study drug. | from date of the start of treatment to the end of the study at 25 days |
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