Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of MK-7762 in Healthy Adults (NCT05824091) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of MK-7762 in Healthy Adults
United States119 participantsStarted 2023-02-23
Plain-language summary
The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of single and then multiple doses of MK-7762 (TBD09) in healthy volunteers in the context of a first-in-human study. The effect of food on the rate and extent of absorption of a single oral dose of MK-7762 (TBD09) will also be evaluated.
Who can participate
Age range
19 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Is ≥ 19 to ≤ 55 years of age.
. Is healthy as determined by the Investigator via medical history and clinical examination before enrollment in the trial.
. Can understand and comply with the trial and site procedures, understand the risks involved in the trial, and provide written informed consent before the first trial-specific procedure.
. Can complete all Screening period evaluations and stay in the clinical research facility for the duration of the inpatient periods of the trial.
. Has BMI between 18 and 32 kg/m2, inclusive, and body weight not less than 50 kg at Screening.
. Has resting vital signs at Screening within the following ranges: Systolic blood pressure (SBP) ≥100 mmHg Diastolic blood pressure (DBP) ≥50 mmHg Heart rate ≤100 beats per minute (bpm) Note: If vital signs are out of range, the Investigator may obtain two additional readings within the Screening period.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Percentage of Participants Reporting Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Timeframe: Day 1 through Day 7
2
Part 1: Percentage of Participants Reporting TEAEs by Severity
Timeframe: Day 1 through Day 7
3
Part 1: Percentage of Participants Reporting Study Drug Related TEAEs
Timeframe: Day 1 through Day 7
4
Part 2: FE Cohort 7: Percentage of Participants Reporting TEAEs, SAEs, and AESIs
Timeframe: Up to Day 7
5
Part 2: FE Cohort 7: Percentage of Participants Reporting Study Drug Related TEAEs
Timeframe: Up to Day 7
6
Part 2: FE Cohort 7: Percentage of Participants Reporting TEAEs by Severity
Timeframe: Up to Day 7
7
Part 2: MAD Cohorts: Percentage of Participants Reporting TEAEs, SAEs, and AESIs
. Has a 12-lead ECG consistent with normal cardiac conduction and function at Screening, including: HR between 45 and 100 bpm (inclusive); QTcF ≤450 ms for males and ≤470 ms for females; QRS interval \<120 ms; PR interval \<220 ms; and morphology consistent with healthy cardiac conduction.
. Is a nonsmoker within the previous 6 months before Screening, and does not use tobacco containing, or nicotine-containing products, including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, e-cigarettes, nicotine patch, or nicotine gum.
Exclusion criteria
3. If individual's assigned sex at birth is female, they must be of non-childbearing potential based on either of the following: a. Is post-menopausal defined as amenorrhea for at least 12 months in absence of any exogenous hormonal treatments and follicle stimulating hormone (FSH) levels in the laboratory-defined postmenopausal range, or, b. Reports being surgically sterilized (i.e., tubal ligation, hysterectomy, bilateral oophorectomy/salpingectomy)
4. If individual is assigned male sex at birth, is not sterilized, and is sexually active with a female partner of childbearing potential, agrees to use condoms from Day -1 through 90 days after the last dose of study drug. They must also agree to not donate sperm during the trial and for 3 months (90 days) after receiving the last dose of study drug.
. Has current or past history of a clinically significant cardiovascular, cerebrovascular, respiratory, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, as determined by the Investigator.
. Has history of or Screening findings of abnormalities of vision, including corrected visual acuity worse than 20/25 in either eye based on Screening assessment using Snellen chart and Rosenbaum pocket chart, or color vision impairment based on Screening assessment using Ishihara plates. Candidates with ametropia corrected to 20/25 or better do not have to be excluded.
. Has history of or Screening findings of peripheral neuropathy, such as numbness or abnormal reflexes.
. Has history of or current clinically relevant cardiovascular disorder, such as heart failure, coronary artery disease, uncontrolled hypertension, arrhythmia, tachyarrhythmia, prolonged QT syndrome, or presence of symptom(s) strongly suggestive of such a problem, such as exertional chest pressure/pain or unexplained syncope.
. Had an active malignancy within 5 years from Screening, except basal cell or squamous cell skin cancers. Any history of breast cancer or melanoma will be exclusionary.
. Has history of any drug abuse within 1 year prior to Screening or has used any hard drugs (such as cocaine, phencyclidine \[PCP\], natural and synthetic opiates, and amphetamine derivatives) within 1 year prior to Screening. Individuals that have taken an opioid or amphetamine medication within the previous year prior to Screening that was prescribed by a healthcare provider will not be excluded unless they are currently taking the medication at the time of Screening.
Timeframe: Day 1 through Day 36.
8
Part 2: MAD Cohorts: Percentage of Participants Reporting TEAEs by Severity
Timeframe: Day 1 through Day 36.
9
Part 2: MAD Cohorts: Proportion of Participants Reporting Study Drug Related TEAEs
Timeframe: Day 1 through Day 36
10
Part 1: Number of Participants With Clinically Significant Changes in Hematology Parameters
Timeframe: Up to Day 7
11
Part 1: Number of Participants With Clinically Significant Changes in Chemistry Parameters
Timeframe: Up to Day 7
12
Part 1: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters
Timeframe: Up to Day 7
13
Part 1: Number of Participants With Clinically Significant Changes in Urinalysis
Timeframe: Up to Day 7
14
Part 1: Number of Participants With Clinically Significant Changes in Vital Parameters
Timeframe: Up to Day 7
15
Part 1: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Timeframe: Up to Day 7
16
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Hematology Parameters
Timeframe: Up to Day 8
17
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Hematology Parameters
Timeframe: Up to Day 36
18
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Chemistry Parameters
Timeframe: Up to Day 8
19
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Chemistry Parameters
Timeframe: Up to Day 36
20
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters
Timeframe: Up to Day 8
21
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Urinalysis
Timeframe: Up to Day 8
22
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters
Timeframe: Up to Day 36
23
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Urinalysis
Timeframe: Up to Day 36
24
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Vital Parameters
Timeframe: Up to Day 8
25
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Vital Parameters
Timeframe: Up to Day 36
26
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in ECG Parameters
Timeframe: Up to Day 8
27
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in ECG Parameters