Trypanosomiasis, AfricanPhase 1OXA-07NCT05947604
DDI Study of Single Oral Dose of Acoziborole With Sequential Co-administration of Midazolam and Dextromethorphan
A Phase 1 study testing Acoziborole, Midazolam and Dextromethorphan in people with Trypanosomiasis, African, run by Drugs for Neglected Diseases at 1 site in Malaysia.
Trial summary
To assess Drug drug interactions between Acoziborole and Dextromethorphan and Midazolam in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Trypanosomiasis, African
- What is being tested?
- Acoziborole, Midazolam and Dextromethorphan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMalaysia
- Study dates
- 9 Feb 2023to 3 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males.
- Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures..
- Age 18 to 55 (inclusive) years of age at the time of signing informed consent.
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 as measured at screening.
- Body weight not less than 50 kg.
- Non-smokers (defined as has not used nicotine-containing products including e-cigarette for at least 3 months prior to the first dose as confirmed by cotinine test).
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- Must be willing and able to communicate and participate in the whole study.
- Normal blood pressure (BP): Systolic BP (SBP) between 90 and 140 mmHg (inclusive), diastolic BP (DBP) between 45 and 90 mmHg (inclusive), measured after 10 min rest in supine position at screening and first admission (Day -1).
- A resting heart rate (HR) between 45 and 90 bpm (inclusive), measured after 10 min rest in supine position at screening and first admission (Day -1).
- ECG recording without clinically significant abnormality, including Fridericia's corrected interval between Q and T waves (QTcF) measure of ≤450 msec at screening and first admission (Day -1).
- Participants must be able to swallow multiple capsules.
Who cannot join
- Have participated in an investigational trial involving administration of any investigational compound within 90 days prior to the study dosing or 5-times the half-life of the drug tested in the previous clinical trial, whichever is longer (time calculated relative to the last dose in the previous clinical trial).
- History of any drug or alcohol abuse in the past 2 years.
- Regular alcohol consumption >14 units per week and (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) as confirmed by a positive alcohol breath test at screening or any on admission to the CRW.
- Participants who do not have suitable veins for multiple venepunctures/cannulations as assessed by the Investigator or delegate at screening.
- Clinically significant abnormal clinical chemistry, haematology, urinalysis, or clinically significant abnormal physical examination findings as judged by the Investigator.
- Abnormal renal function (estimate glomerular filtration rate [eGFR] <90 mL/min).
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- Confirmed positive drugs of abuse urine test result (including but not limited to, amphetamines, tetrahydrocannabinol, morphine, methamphetamine, ketamine and benzodiazepines) and at any time during the study.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
- Positive COVID test at screening and at admission of hospitalisation.
- COVID-19 full vaccination to be received less than 21 days before Day 1, or start of vaccination, or second dose or booster of vaccination planned during the study period.
- Clinically significant medical condition and/or abnormal laboratory results that could, in the opinion of the Investigator, jeopardize the participant's safety or participation in the study.
- Known serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients in the past.
- Presence or history of clinically significant allergy requiring treatment (including asthma, urticaria, clinically significant allergic rash or other severe allergic diathesis), as judged by the Investigator. Hay fever is allowed unless it is active.
- Donation or loss of greater than 400 mL of blood within the previous 3 months or more than 100 mL within 30 days before signing informed consent form (ICF) to this trial.
- Participants who are taking any prescribed drug in the 30 days before screening or require regular use of any prescription medication during the study.
- Participants who have taken, any OTC medications, including vitamins, analgesics or antacids, herbal remedies, St. John's wort or diet complements (plants and vitamins that may be used for e.g. weight control or improve digestion or for "detox"... e.g., found in the composition extracts of ginkgo biloba, aesculus, cassia, harpagophytum, curcuma, elderberry, Vitis vinifera, cypress (Cupressus sempervirens)) in the 30 days before investigational medicinal product (IMP) administration. Exceptions may apply on a case-by-case basis, if considered not to interfere with the objectives of the study, as determined by the Principal Investigator (PI).
- Use of enzyme-altering drugs (e.g. barbiturates, phenothiazines, cimetidine) within 30 days or 5 half-lives, whichever is longer, of study Day 1.
- Use of products containing quinine (e.g., tonic water), grapefruit products, pomelo products, Seville orange products, supplements containing citrus aurantium and bitter orange in the 30 days prior to study Day 1.
- CYP2D6 poor metabolizers, based on genotyping of DNA from blood samples.
- Surgery within 12 weeks prior to screening, with the exception of appendectomy or at the discretion of the Investigator for minor surgery.
- Any surgery (e.g. gastric bypass) or medical condition that may affect absorption of orally administered drugs.
- Failure to satisfy the Investigator of fitness to participate for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Centre Open-label, Non-randomised, 3-treatment, 2-period, Pharmacokinetic Drug Interaction Study of Single Oral Dose of Acoziborole With Sequential Co-administration of Midazolam and Dextromethorphan in Healthy Male Participants
To assess Drug drug interactions between Acoziborole and Dextromethorphan and Midazolam in healthy male volunteers.
Read the detailed description
An in silico PB-PK model was developed within the simCYP software and qualified for acoziborole. This study suggested strong interactions with sensitive index substrates of CYP2D6 and CYP3A4.To validate these PB-PK model results, an open-label, non-randomised, three-treatment, one-sequence, two successive periods study with at least 3-day washout between periods was chosen to evaluate clinically the potential impact of acoziborole on plasma exposure of two different sensitive CYP substrates, DXM for CYP2D6 and midazolam for CYP3A4.
Acoziborole will be administered as a single dose, due to the long t1/2 of 360 h in healthy participants.
The SimCYP simulations showed that the best compromise to maximize the CYP2D6 inhibition and minimize the CYP3A4 induction is when DXM is given 24 to 60 h after acoziborole administration. Therefore, dextromethorphan will be given on Day 1 (in Period 1, without acoziborole) and on Day 14 in Period 2 i.e. 2 days following oral administration of acoziborole.
Based on the PB-PK simulations, the interaction between acoziborole and midazolam should be maximal around Day 8 (due to the activity CYP3A4) following acoziborole administration and sustained for several weeks after. Thus, midazolam will be given on Day 8 (in Period 1 without acoziborole) and on Day 21 in Period 2 i.e. 9 days following oral single administration of acoziborole.
- Conditions
- Trypanosomiasis, African
- Being tested
- Acoziborole, Midazolam, Dextromethorphan
- Medical subject headings
- Trypanosomiasis, African
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcoziboroleDrug
Acoziborole 960 mg (three tablets of 320 mg) for oral route in fasted condition Period 2: single oral administration on Day 12
MidazolamDrug
- Midazolam 5 mg syrup in fasted condition Period 1: Single oral dose of 5 mg administered on Day 8 Period 2: Single oral dose of 5 mg administered on Day 21
DextromethorphanDrug
- Dextromethorphan 15 mg syrup in fasted condition Period 1: Single oral dose of 15 mg administered on Day 1 Period 2: Single oral dose of 15 mg administered on Day 14
| Study group | Role | What they receive |
|---|---|---|
| Dextromethorphan and Midazolam | Other | Drug drug interaction Dextromethorphan and Midazolam administrations
* Dextromethorphan 15 mg syrup in fasted condition Period 1: Single oral dose of 15 mg administered on Day 1
* Midazolam 5 mg syrup in fasted condition Period 1: Single oral dose of 5 mg administered on Day 8 Receives: Drug: Midazolam; Drug: Dextromethorphan |
| Acoziborole, Dextromethorphan and Midazolam | Other | Drug drug interaction Acoziborole, Dextromethorphan and Midazolam administrations
* Acoziborole 960 mg (three tablets of 320 mg) for oral route in fasted condition Period 2: single oral administration on Day 12
* Dextromethorphan 15 mg syrup in fasted condition Period 2: Single oral dose of 15 mg administered on Day 14
* Midazolam 5 mg syrup in fasted condition Period 2: Single oral dose of 5 mg administered on Day 21 Receives: Drug: Acoziborole; Drug: Midazolam; Drug: Dextromethorphan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of single dose of acoziborole on pharmacokinetics (PK) parameters (Cmax) of midazolam as a probe substrate for CYP3A4 (induction)
Midazolam Cmax, plasma concentration
Measured: Up to 72 hours post drug administration
To assess the effect of single dose of acoziborole on pharmacokinetics (PK) parameters (Cmax) of dextromethorphan as a probe substrate for CYP2D6 (inhibition).
Dextromethorphan Cmax, plasma concentration
Measured: Up to 72 hours post drug administration
To assess the effect of single dose of acoziborole on pharmacokinetics (PK) parameters ( AUC0-t) of midazolam as a probe substrate for CYP3A4 (induction)
Midazolam AUC0-t (plasma concentration) of Period 1 and Period 2.
Measured: Up to 72 hours post drug administration
To assess the effect of single dose of acoziborole on pharmacokinetics (PK) parameters ( AUC0-t) of dextromethorphan as a probe substrate for CYP2D6 (inhibition).
Dextromethorphan AUC0-t (plasma concentration) of Period 1 and Period 2.
Measured: Up to 72 hours post drug administration
To assess the effect of single dose of acoziborole on pharmacokinetics (PK) parameters (AUC0-24) of midazolam as a probe substrate for CYP3A4 (induction)
Midazolam AUC0-24 (plasma concentration) of Period 1 and Period 2
Measured: Up to 72 hours post drug administration
To assess the effect of single dose of acoziborole on pharmacokinetics (PK) parameters (AUC0-24) of dextromethorphan as a probe substrate for CYP2D6 (inhibition).
Dextromethorphan AUC0-24 of Period 1 and Period 2.
Measured: Up to 72 hours post drug administration
Secondary outcomes (63)
To evaluate the clinical and laboratory safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Frequency and cumulative incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) from time of first IMP administration (dextromethorphan on Day 1 in Period 1) to EoS visit.
Measured: Up to End of Study Visit, Day 31
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: Height
Vital signs for safety monitoring: Height (cm)
Measured: Baseline
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: weight
Vital signs for safety monitoring: Weight (Kgs)
Measured: Baseline and End of Study (Day 28 to Day 31)
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: Sistolic and Diastolic BP
Vital signs for safety monitoring: Sistolic BP and Diastolic BP (mmHg)
Measured: Up to End of Study (Day 28 to Day 31)
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: respiratory rate
Vital signs for safety monitoring: respiratory rate (breaths/minute)
Measured: Up to End of Study (Day 28 to Day 31)
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: ear body temperature
Vital signs for safety monitoring: ear body temperature (°C).
Measured: Up to End of Study (Day 28 to Day 31)
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: 12-lead ECG Heart Rate
12-lead electrocardiogram (ECG) Heart Rate for safety monitoring purpose. ECGs for safety purpose will be performed using the internationally recognized 12 leads with devices recorder after 10 min rest in supine position and before any blood draws. ECG will be recorded at a standard paper speed of 25 mm/s and gain of 10 mm/mV. Print-outs for each ECG will include: date, time, initials of the Investigator or its deputy.
The ECGs will be performed in 6 × 2 leads during this study. The corresponding source data will consist of the ECG recorder paper print-outs.
The ECGs will be read and analysed by the Investigator.
Measured: Up to Day 22
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: 12-lead ECG RR Interval
12-lead electrocardiogram (ECG) RR Interval for safety monitoring purpose. ECGs for safety purpose will be performed using the internationally recognized 12 leads with devices recorder after 10 min rest in supine position and before any blood draws. ECG will be recorded at a standard paper speed of 25 mm/s and gain of 10 mm/mV. Print-outs for each ECG will include: date, time, initials of the Investigator or its deputy.
The ECGs will be performed in 6 × 2 leads during this study. The corresponding source data will consist of the ECG recorder paper print-outs.
The ECGs will be read and analysed by the Investigator.
Measured: Up to Day 22
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: 12-lead ECG QRS duration
12-lead electrocardiogram (ECG) QRS duration for safety monitoring purpose. ECGs for safety purpose will be performed using the internationally recognized 12 leads with devices recorder after 10 min rest in supine position and before any blood draws. ECG will be recorded at a standard paper speed of 25 mm/s and gain of 10 mm/mV. Print-outs for each ECG will include: date, time, initials of the Investigator or its deputy.
The ECGs will be performed in 6 × 2 leads during this study. The corresponding source data will consist of the ECG recorder paper print-outs.
The ECGs will be read and analysed by the Investigator.
Measured: Up to Day 22
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: 12-lead ECG QT-interval
12-lead electrocardiogram (ECG) QT-interval for safety monitoring purpose. ECGs for safety purpose will be performed using the internationally recognized 12 leads with devices recorder after 10 min rest in supine position and before any blood draws. ECG will be recorded at a standard paper speed of 25 mm/s and gain of 10 mm/mV. Print-outs for each ECG will include: date, time, initials of the Investigator or its deputy.
The ECGs will be performed in 6 × 2 leads during this study. The corresponding source data will consist of the ECG recorder paper print-outs.
The ECGs will be read and analysed by the Investigator.
Measured: Up to Day 22
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: 12-lead ECG QTcF-interval
12-lead electrocardiogram (ECG) QTcF-interval for safety monitoring purpose. ECGs for safety purpose will be performed using the internationally recognized 12 leads with devices recorder after 10 min rest in supine position and before any blood draws. ECG will be recorded at a standard paper speed of 25 mm/s and gain of 10 mm/mV. Print-outs for each ECG will include: date, time, initials of the Investigator or its deputy.
The ECGs will be performed in 6 × 2 leads during this study. The corresponding source data will consist of the ECG recorder paper print-outs.
The ECGs will be read and analysed by the Investigator.
Measured: Up to Day 22
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: 12-lead ECG PR Interval
12-lead electrocardiogram (ECG) PR Interval for safety monitoring purpose. ECGs for safety purpose will be performed using the internationally recognized 12 leads with devices recorder after 10 min rest in supine position and before any blood draws. ECG will be recorded at a standard paper speed of 25 mm/s and gain of 10 mm/mV. Print-outs for each ECG will include: date, time, initials of the Investigator or its deputy.
The ECGs will be performed in 6 × 2 leads during this study. The corresponding source data will consist of the ECG recorder paper print-outs.
The ECGs will be read and analysed by the Investigator.
Measured: Up to Day 22
To evaluate the laboratory safety, Hemoglobin, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, hemoglobin, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, Red blood cell count, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, Red blood cell count, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, hematocrit, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, hematocrit, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, white blood cells count, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, white blood cells count, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, mean corpuscular volume, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, mean corpuscular volume, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, mean corpuscular hemoglobin, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, mean corpuscular hemoglobin, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, red cell distribution width, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, red cell distribution width, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, neutrophils, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, neutrophils, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, lymphocytes, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, lymphocytes, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, monocytes, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, monocytes, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, eosinophils, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, eosinophils, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, basophils, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, basophils, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, platelet count, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, platelet count, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, ALP, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, ALP, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, ALT, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, ALT, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, AST, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, AST, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, GGT, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, GGT, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, CPK, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, CPK, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, total bilirubin, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, total bilirubin, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, direct bilirubin, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, direct bilirubin, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, indirect bilirubin, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, indirect bilirubin, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, total protein, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, total protein, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, albumin, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, albumin, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, creatinine, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, creatinine, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, eGFR, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, eGFR, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, fasting glucose, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, fasting glucose, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, urea, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, urea, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, calcium, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, calcium, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, Na+, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, Na+, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, K+, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, K+, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, Cl-, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, Cl-, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the laboratory safety, bicarbonates, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Laboratory safety assessments, bicarbonates, from baseline to EoS visit.
Measured: Up to Day 22
To evaluate the Tmax of midazolam when co-administered with acoziborole.
Time to maximum observed plasma concentration (tmax) for midazolam
Measured: Up to Day 22
To evaluate the Tmax of dextromethorphan when co-administered with acoziborole.
Time to maximum observed plasma concentration (tmax) for dextromethorphan.
Measured: Up to Day 22
To evaluate the apparent terminal elimination half-life of midazolam when co-administered with acoziborole.
Apparent terminal elimination half-life (t½) for midazolam
Measured: Up to Day 22
To evaluate the apparent terminal elimination half-life of dextromethorphan, when co-administered with acoziborole.
Apparent terminal elimination half-life (t½) for dextromethorphan.
Measured: Up to Day 22
To evaluate the AUC0-∞ of midazolam when co-administered with acoziborole.
AUC0-∞ for midazolam
Measured: Up to Day 22
To evaluate the AUC0-∞ of dextromethorphan when co-administered with acoziborole.
AUC0-∞ for dextromethorphan.
Measured: Up to Day 22
To evaluate the Acoziborole plasma concentrations when co-administered with midazolam and dextromethorpharm
Acoziborole plasma concentrations
Measured: Up to Day 22
To evaluate the Cmax of midazolam's metabolite, 1'hydroxy-midazolam, when co-administered with acoziborole.
1'-hydroxy-midazolam: Cmax for Period 1 and Period 2.
Measured: Up to Day 22
To evaluate the Tmax of midazolam's metabolite, 1'hydroxy-midazolam, when co-administered with acoziborole.
1'-hydroxy-midazolam: tmax for Period 1 and Period 2.
Measured: Up to Day 22
To evaluate the AUC0-24 of midazolam's metabolite, 1'hydroxy-midazolam, when co-administered with acoziborole.
1'-hydroxy-midazolam:AUC0-24 for Period 1 and Period 2.
Measured: Up to Day 22
To evaluate the AUC0-t of midazolam's metabolite, 1'hydroxy-midazolam, when co-administered with acoziborole.
1'-hydroxy-midazolam: AUC0-t for Period 1 and Period 2.
Measured: Up to Day 22
To evaluate the t½ of midazolam's metabolite, 1'hydroxy-midazolam, when co-administered with acoziborole.
1'-hydroxy-midazolam: t½ for Period 1 and Period 2.
Measured: Up to Day 22
To evaluate the AUC0-∞ of midazolam's metabolite, 1'hydroxy-midazolam, when co-administered with acoziborole.
1'-hydroxy-midazolam: AUC0-∞ for Period 1 and Period 2.
Measured: Up to Day 22
To evaluate the Cmax of dextromethorphan's metabolite, dextrorphan (DXO), when co-administered with acoziborole.
DXO: Cmax for Period 1 and Period 2.
Measured: Up to Day 22
To evaluate the Tmax of dextromethorphan's metabolite, dextrorphan (DXO), when co-administered with acoziborole.
DXO: tmax for Period 1 and Period 2.
Measured: Up to Day 22
To evaluate the AUC0-24 of dextromethorphan's metabolite, dextrorphan (DXO), when co-administered with acoziborole.
DXO: AUC0-24 for Period 1 and Period 2.
Measured: Up to Day 22
To evaluate the AUC0-t of dextromethorphan's metabolite, dextrorphan (DXO), when co-administered with acoziborole.
DXO: AUC0-t for Period 1 and Period 2.
Measured: Up to Day 22
To evaluate the t½ of dextromethorphan's metabolite, dextrorphan (DXO), when co-administered with acoziborole.
DXO: t½ for Period 1 and Period 2.
Measured: Up to Day 22
To evaluate the AUC0-∞ of dextromethorphan's metabolite, dextrorphan (DXO), when co-administered with acoziborole.
DXO: AUC0-∞ for Period 1 and Period 2.
Measured: Up to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start9 Feb 2023
- Primary completion3 May 2023
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trypanosomiasis, AfricanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- On Period 1, participants will receive: A single oral dose of Dextromethorphan on Day and of midazolam on Day 8. On Period 2, participants will receive: A single oral dose of acoziborole on Day 12, of dextromethorphan on Day 14, and of midazolam on Day 21. The study duration will be approximately 8 weeks: Screening period before the first study drug administration, Period 1 with a hospitalisation period from the day before the first dose of dextromethorphan until 24 h after the first dose of midazolam, Wash-out period: 3 days, Period 2 with a hospitalisation period from the day before the single administration of acoziborole until 24 h after the last dose of midazolam . End of study (EoS) visit between 7-10 days after last dose of midazolam on Period 2
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon Ng Shi Min, Principal investigator, Clinical Research Center (CRC) Ampang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947604
- Sponsor's protocol ID
- DNDi-OXA-07-HAT
- Acronym
- OXA-07
- Status last verified
- Jun 2023
- First submitted
- 5 Mar 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Centre Open-label, Non-randomised, 3-treatment, 2-period, Pharmacokinetic Drug Interaction Study of Single Oral Dose of Acoziborole With Sequential Co-administration of Midazolam and Dextromethorphan in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT05947604
- Acronym / sponsor ID
- OXA-07 / DNDi-OXA-07-HAT
- Conditions
- Trypanosomiasis, African
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess Drug drug interactions between Acoziborole and Dextromethorphan and Midazolam in healthy male volunteers.
Detailed description
An in silico PB-PK model was developed within the simCYP software and qualified for acoziborole. This study suggested strong interactions with sensitive index substrates of CYP2D6 and CYP3A4.To validate these PB-PK model results, an open-label, non-randomised, three-treatment, one-sequence, two successive periods study with at least 3-day washout between periods was chosen to evaluate clinically the potential impact of acoziborole on plasma exposure of two different sensitive CYP substrates, DXM for CYP2D6 and midazolam for CYP3A4.
Acoziborole will be administered as a single dose, due to the long t1/2 of 360 h in healthy participants.
The SimCYP simulations showed that the best compromise to maximize the CYP2D6 inhibition and minimize the CYP3A4 induction is when DXM is given 24 to 60 h after acoziborole administration. Therefore, dextromethorphan will be given on Day 1 (in Period 1, without acoziborole) and on Day 14 in Period 2 i.e. 2 days following oral administration of acoziborole.
Based on the PB-PK simulations, the interaction between acoziborole and midazolam should be maximal around Day 8 (due to the activity CYP3A4) following acoziborole administration and sustained for several weeks after. Thus, midazolam will be given on Day 8 (in Period 1 without acoziborole) and on Day 21 in Period 2 i.e. 9 days following oral single administration of acoziborole.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- On Period 1, participants will receive: A single oral dose of Dextromethorphan on Day and of midazolam on Day 8. On Period 2, participants will receive: A single oral dose of acoziborole on Day 12, of dextromethorphan on Day 14, and of midazolam on Day 21. The study duration will be approximately 8 weeks: Screening period before the first study drug administration, Period 1 with a hospitalisation period from the day before the first dose of dextromethorphan until 24 h after the first dose of midazolam, Wash-out period: 3 days, Period 2 with a hospitalisation period from the day before the single administration of acoziborole until 24 h after the last dose of midazolam . End of study (EoS) visit between 7-10 days after last dose of midazolam on Period 2
| Arm | Type | Receives |
|---|---|---|
| Dextromethorphan and Midazolam | Other | Drug: Midazolam, Drug: DextromethorphanDrug drug interaction Dextromethorphan and Midazolam administrations * Dextromethorphan 15 mg syrup in fasted condition Period 1: Single oral dose of 15 mg administered on Day 1 * Midazolam 5 mg syrup in fasted condition Period 1: Single oral dose of 5 mg administered on Day 8 |
| Acoziborole, Dextromethorphan and Midazolam | Other | Drug: Acoziborole, Drug: Midazolam, Drug: DextromethorphanDrug drug interaction Acoziborole, Dextromethorphan and Midazolam administrations * Acoziborole 960 mg (three tablets of 320 mg) for oral route in fasted condition Period 2: single oral administration on Day 12 * Dextromethorphan 15 mg syrup in fasted condition Period 2: Single oral dose of 15 mg administered on Day 14 * Midazolam 5 mg syrup in fasted condition Period 2: Single oral dose of 5 mg administered on Day 21 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy males.
- Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures..
- Age 18 to 55 (inclusive) years of age at the time of signing informed consent.
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 as measured at screening.
- Body weight not less than 50 kg.
Key exclusion criteria (22 listed)
- Have participated in an investigational trial involving administration of any investigational compound within 90 days prior to the study dosing or 5-times the half-life of the drug tested in the previous clinical trial, whichever is longer (time calculated relative to the last dose in the previous clinical trial).
- History of any drug or alcohol abuse in the past 2 years.
- Regular alcohol consumption >14 units per week and (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) as confirmed by a positive alcohol breath test at screening or any on admission to the CRW.
- Participants who do not have suitable veins for multiple venepunctures/cannulations as assessed by the Investigator or delegate at screening.
- Clinically significant abnormal clinical chemistry, haematology, urinalysis, or clinically significant abnormal physical examination findings as judged by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcoziboroleAcoziborole 960 mg (three tablets of 320 mg) for oral route in fasted condition Period 2: single oral administration on Day 12 | Drug | Acoziborole, Dextromethorphan and Midazolam |
| Midazolam• Midazolam 5 mg syrup in fasted condition Period 1: Single oral dose of 5 mg administered on Day 8 Period 2: Single oral dose of 5 mg administered on Day 21 | Drug | Acoziborole, Dextromethorphan and Midazolam, Dextromethorphan and Midazolam |
| Dextromethorphan• Dextromethorphan 15 mg syrup in fasted condition Period 1: Single oral dose of 15 mg administered on Day 1 Period 2: Single oral dose of 15 mg administered on Day 14 | Drug | Acoziborole, Dextromethorphan and Midazolam, Dextromethorphan and Midazolam |
Primary outcome
To assess the effect of single dose of acoziborole on pharmacokinetics (PK) parameters (Cmax) of midazolam as a probe substrate for CYP3A4 (induction)
Time frame: Up to 72 hours post drug administration
Midazolam Cmax, plasma concentration
To assess the effect of single dose of acoziborole on pharmacokinetics (PK) parameters (Cmax) of dextromethorphan as a probe substrate for CYP2D6 (inhibition).
Time frame: Up to 72 hours post drug administration
Dextromethorphan Cmax, plasma concentration
To assess the effect of single dose of acoziborole on pharmacokinetics (PK) parameters ( AUC0-t) of midazolam as a probe substrate for CYP3A4 (induction)
Time frame: Up to 72 hours post drug administration
Midazolam AUC0-t (plasma concentration) of Period 1 and Period 2.
To assess the effect of single dose of acoziborole on pharmacokinetics (PK) parameters ( AUC0-t) of dextromethorphan as a probe substrate for CYP2D6 (inhibition).
Time frame: Up to 72 hours post drug administration
Dextromethorphan AUC0-t (plasma concentration) of Period 1 and Period 2.
To assess the effect of single dose of acoziborole on pharmacokinetics (PK) parameters (AUC0-24) of midazolam as a probe substrate for CYP3A4 (induction)
Time frame: Up to 72 hours post drug administration
Midazolam AUC0-24 (plasma concentration) of Period 1 and Period 2
To assess the effect of single dose of acoziborole on pharmacokinetics (PK) parameters (AUC0-24) of dextromethorphan as a probe substrate for CYP2D6 (inhibition).
Time frame: Up to 72 hours post drug administration
Dextromethorphan AUC0-24 of Period 1 and Period 2.
63 secondary outcomes
To evaluate the clinical and laboratory safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to End of Study Visit, Day 31
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: Height
Time frame: Baseline
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: weight
Time frame: Baseline and End of Study (Day 28 to Day 31)
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: Sistolic and Diastolic BP
Time frame: Up to End of Study (Day 28 to Day 31)
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: respiratory rate
Time frame: Up to End of Study (Day 28 to Day 31)
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: ear body temperature
Time frame: Up to End of Study (Day 28 to Day 31)
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: 12-lead ECG Heart Rate
Time frame: Up to Day 22
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: 12-lead ECG RR Interval
Time frame: Up to Day 22
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: 12-lead ECG QRS duration
Time frame: Up to Day 22
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: 12-lead ECG QT-interval
Time frame: Up to Day 22
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: 12-lead ECG QTcF-interval
Time frame: Up to Day 22
To evaluate the clinical safety of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone: 12-lead ECG PR Interval
Time frame: Up to Day 22
To evaluate the laboratory safety, Hemoglobin, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, Red blood cell count, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, hematocrit, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, white blood cells count, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, mean corpuscular volume, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, mean corpuscular hemoglobin, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, red cell distribution width, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, neutrophils, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, lymphocytes, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, monocytes, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, eosinophils, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, basophils, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, platelet count, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, ALP, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, ALT, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, AST, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, GGT, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, CPK, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, total bilirubin, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, direct bilirubin, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, indirect bilirubin, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, total protein, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, albumin, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, creatinine, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, eGFR, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, fasting glucose, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, urea, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
To evaluate the laboratory safety, calcium, of acoziborole co-administered with midazolam and dextromethorphan as compared to administration of midazolam and dextromethorphan alone.
Time frame: Up to Day 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Ng Shi Min principal investigator
Clinical Research Center (CRC) Ampang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acoziborole, Midazolam and Dextromethorphan in people with Trypanosomiasis, African, run by Drugs for Neglected Diseases at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effect of single dose of acoziborole on pharmacokinetics (PK) parameters (Cmax) of midazolam as a probe substrate for CYP3A4 (induction) (time frame: Up to 72 hours post drug administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.