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CompletedNCT05947604OXA-07Updated Jul 17, 2023

DDI Study of Single Oral Dose of Acoziborole With Sequential Co-administration of Midazolam and Dextromethorphan

A Phase 1 interventional study of Acoziborole and Midazolam in Trypanosomiasis, African, sponsored by Drugs for Neglected Diseases. Completed at 1 site in Malaysia. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-17.

Sponsored by Drugs for Neglected Diseases · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Trypanosomiasis, African
03

In context

Trypanosomiasis, African

26 studies on the registry are indexed under Trypanosomiasis, African; 1 is open to participants now.

This study's enrollment of 20 is below the median of 155 across 24 interventional studies indexed under Trypanosomiasis, African.

Browse Trypanosomiasis, African studies →

Lead sponsor

Drugs for Neglected Diseases is the lead sponsor of 58 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy males.
  • Have the ability to understand and sign a written 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.
  • (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).
  • 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).
  • recording without abnormality, including Fridericia's corrected interval between Q and T waves () measure of ≤450 msec at screening and first admission (Day -1).
  • Participants must be able to swallow multiple capsules.

Exclusion criteria

Exclusion Criteria:

  • Have participated in an 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.
  • abnormal clinical chemistry, haematology, urinalysis, or clinically significant abnormal physical examination findings as judged by the Investigator.
  • Abnormal renal function (estimate [eGFR] \<90 mL/min).
  • 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 surface antigen (HBsAg), virus antibody (HCV Ab) or (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 to any drug or the formulation 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 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.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Other
    Dextromethorphan and Midazolam

    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

    Drug: Midazolam · Drug: Dextromethorphan

  • Other
    Acoziborole, Dextromethorphan and Midazolam

    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

    Drug: Acoziborole · Drug: Midazolam · Drug: Dextromethorphan

Interventions

  • DrugAcoziborole

    Acoziborole 960 mg (three tablets of 320 mg) for oral route in fasted condition Period 2: single oral administration on Day 12

  • DrugMidazolam

    • 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

  • DrugDextromethorphan

    • 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to 72 hours post drug administration

  2. 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

    Time frame: Up to 72 hours post drug administration

  3. 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.

    Time frame: Up to 72 hours post drug administration

  4. 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.

    Time frame: Up to 72 hours post drug administration

  5. 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

    Time frame: Up to 72 hours post drug administration

  6. 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.

    Time frame: Up to 72 hours post drug administration

Secondary outcomes

  1. 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.

    Time frame: Up to End of Study Visit, Day 31

  2. 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)

    Time frame: Baseline

  3. 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)

    Time frame: Baseline and End of Study (Day 28 to Day 31)

  4. 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)

    Time frame: Up to End of Study (Day 28 to Day 31)

  5. 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)

    Time frame: Up to End of Study (Day 28 to Day 31)

  6. 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).

    Time frame: Up to End of Study (Day 28 to Day 31)

  7. 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.

    Time frame: Up to Day 22

  8. 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.

    Time frame: Up to Day 22

  9. 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.

    Time frame: Up to Day 22

  10. 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.

    Time frame: Up to Day 22

  11. 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.

    Time frame: Up to Day 22

  12. 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.

    Time frame: Up to Day 22

  13. 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.

    Time frame: Up to Day 22

  14. 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.

    Time frame: Up to Day 22

  15. 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.

    Time frame: Up to Day 22

  16. 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.

    Time frame: Up to Day 22

  17. 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.

    Time frame: Up to Day 22

  18. 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.

    Time frame: Up to Day 22

  19. 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.

    Time frame: Up to Day 22

  20. 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.

    Time frame: Up to Day 22

  21. 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.

    Time frame: Up to Day 22

  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.

    Time frame: Up to Day 22

  23. 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.

    Time frame: Up to Day 22

  24. 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.

    Time frame: Up to Day 22

  25. 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.

    Time frame: Up to Day 22

  26. 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.

    Time frame: Up to Day 22

  27. 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.

    Time frame: Up to Day 22

  28. 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.

    Time frame: Up to Day 22

  29. 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.

    Time frame: Up to Day 22

  30. 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.

    Time frame: Up to Day 22

  31. 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.

    Time frame: Up to Day 22

  32. 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.

    Time frame: Up to Day 22

  33. 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.

    Time frame: Up to Day 22

  34. 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.

    Time frame: Up to Day 22

  35. 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.

    Time frame: Up to Day 22

  36. 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.

    Time frame: Up to Day 22

  37. 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.

    Time frame: Up to Day 22

  38. 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.

    Time frame: Up to Day 22

  39. 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.

    Time frame: Up to Day 22

  40. 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.

    Time frame: Up to Day 22

  41. 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.

    Time frame: Up to Day 22

  42. 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.

    Time frame: Up to Day 22

  43. 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.

    Time frame: Up to Day 22

  44. 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.

    Time frame: Up to Day 22

  45. To evaluate the Tmax of midazolam when co-administered with acoziborole.

    Time to maximum observed plasma concentration (tmax) for midazolam

    Time frame: Up to Day 22

  46. To evaluate the Tmax of dextromethorphan when co-administered with acoziborole.

    Time to maximum observed plasma concentration (tmax) for dextromethorphan.

    Time frame: Up to Day 22

  47. To evaluate the apparent terminal elimination half-life of midazolam when co-administered with acoziborole.

    Apparent terminal elimination half-life (t½) for midazolam

    Time frame: Up to Day 22

  48. To evaluate the apparent terminal elimination half-life of dextromethorphan, when co-administered with acoziborole.

    Apparent terminal elimination half-life (t½) for dextromethorphan.

    Time frame: Up to Day 22

  49. To evaluate the AUC0-∞ of midazolam when co-administered with acoziborole.

    AUC0-∞ for midazolam

    Time frame: Up to Day 22

  50. To evaluate the AUC0-∞ of dextromethorphan when co-administered with acoziborole.

    AUC0-∞ for dextromethorphan.

    Time frame: Up to Day 22

  51. To evaluate the Acoziborole plasma concentrations when co-administered with midazolam and dextromethorpharm

    Acoziborole plasma concentrations

    Time frame: Up to Day 22

  52. 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.

    Time frame: Up to Day 22

  53. 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.

    Time frame: Up to Day 22

  54. 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.

    Time frame: Up to Day 22

  55. 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.

    Time frame: Up to Day 22

  56. 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.

    Time frame: Up to Day 22

  57. 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.

    Time frame: Up to Day 22

  58. To evaluate the Cmax of dextromethorphan's metabolite, dextrorphan (DXO), when co-administered with acoziborole.

    DXO: Cmax for Period 1 and Period 2.

    Time frame: Up to Day 22

  59. To evaluate the Tmax of dextromethorphan's metabolite, dextrorphan (DXO), when co-administered with acoziborole.

    DXO: tmax for Period 1 and Period 2.

    Time frame: Up to Day 22

  60. 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.

    Time frame: Up to Day 22

  61. 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.

    Time frame: Up to Day 22

  62. To evaluate the t½ of dextromethorphan's metabolite, dextrorphan (DXO), when co-administered with acoziborole.

    DXO: t½ for Period 1 and Period 2.

    Time frame: Up to Day 22

  63. To evaluate the AUC0-∞ of dextromethorphan's metabolite, dextrorphan (DXO), when co-administered with acoziborole.

    DXO: AUC0-∞ for Period 1 and Period 2.

    Time frame: Up to Day 22

07

Study locations

1 site
  • Clinical Research Center (CRC) Ampang Hospital
    Kuala Lumpur, Malaysia
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05947604
Lead sponsor
Drugs for Neglected Diseases
Responsible party
Sponsor
First posted
Jul 17, 2023
Start date
Feb 9, 2023
Primary completion
May 3, 2023
Completion
May 3, 2023
Last update
Jul 17, 2023

Study contacts

Sharon Ng Shi Min
principal investigator · Clinical Research Center (CRC) Ampang Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: SCYX 7158

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