CompletedPhase 1

A Study of VRG50635 in Healthy Volunteers

United States22 participantsStarted 2024-02-29

Plain-language summary

The primary objectives of this study are to investigate the safety and tolerability of VRG50635 and to determine how VRG50635 is absorbed by the body.

Who can participate

Age range19 Years – 55 Years

SexALL

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

✓. Must be ≥ 19 and ≤ 55 years of age at Screening.
✓. Must be willing and able to voluntarily give written informed consent by signing an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to any study-related procedures being performed.
✓. Must have a body mass index ≥ 18.5 and ≤ 32 kilogram per square meter (kg/m2) and weigh ≥ 50 kg.
✓. Participants of childbearing potential are eligible to participate if they are not pregnant or breastfeeding and agree to use one highly effective and one barrier method of contraception, if sexually active, for the duration of the study through 90 days after the last study drug administration. Participants must not donate eggs for the duration of study through 90 days after the last dose of study drug.
✓. Participants capable of producing sperm must agree that they will use one barrier method of contraception and that their partners of childbearing potential will use one highly effective method of contraception for the duration of the study through 90 days after the last study drug administration. Participants must not donate sperm for the duration of study through 90 days after the last dose of study drug.

Exclusion criteria

✕. Have a history of clinically significant hematologic, renal, neurologic, pancreatic, gastrointestinal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, immunological, allergic disease, or other major disorders, as determined by the PI.
✕. Have any surgical or medical condition that could possibly affect drug absorption (including inflammatory bowel disease, history of gastrectomy, cholecystectomy, or other gastrointestinal tract surgery except appendectomy).
✕. Have a current significant medical or psychiatric condition, as determined by the PI.
✕. Have a history of serious adverse reaction or serious hypersensitivity to any drug.
✕. Have, in the opinion of the PI, evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> the upper limit of normal (ULN) or bilirubin \> 1.5 × ULN. Note: Participants with Gilbert syndrome without evidence of hepatic impairment may be enrolled.
✕. Have a history or presence of an abnormal electrocardiogram (ECG), including, but not limited to, complete left bundle branch block, second- or third-degree heart block, evidence of prior myocardial infarction, or any other abnormality that is clinically significant in the PI's opinion or precludes accurate interpretation and calculations of cardiac intervals (e.g., QT, QRS).
✕. Have clinically significant abnormalities, as assessed by the PI, in laboratory tests at the screening and admission visits. Note: Participants may be rescreened at the discretion of the PI with Sponsor approval.
✕. Have abnormal blood pressure: supine systolic blood pressure \< 90 or \> 140 mmHg, supine diastolic blood pressure \< 50 or \> 90 mmHg, pulse rate \< 40 or \> 100 bpm, and body temperature \< 35.4 or \> 37.8 °C (\< 96 or \> 100.3 °F) at the screening and admission visits.

What they're measuring

Number of Participants with Adverse Events

Timeframe: Up to Day 30

Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUCinf)

Timeframe: Up to Day 16

Area Under the Concentration-time Curve from Time 0 to the Last Measurable Concentration (AUClast)

Timeframe: Up to Day 16

Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-dose (AUC0-24)

Timeframe: Up to Day 16

Area Under the Concentration-time Curve Between Consecutive Doses (AUCtau)

Timeframe: Up to Day 16

Maximum Observed Concentration (Cmax)

Timeframe: Up to Day 16

Half-life (t1/2)

Timeframe: Up to Day 16

Time of Maximal Plasma Concentration (tmax)

Timeframe: Up to Day 16

Trial details

NCT IDNCT06286475

SponsorVerge Genomics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-25

View on ClinicalTrials.gov More Healthy Volunteers trials

Who can participate

Age range19 Years – 55 Years

SexALL

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

✓. Must be ≥ 19 and ≤ 55 years of age at Screening.
✓. Must be willing and able to voluntarily give written informed consent by signing an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to any study-related procedures being performed.
✓. Must have a body mass index ≥ 18.5 and ≤ 32 kilogram per square meter (kg/m2) and weigh ≥ 50 kg.
✓. Participants of childbearing potential are eligible to participate if they are not pregnant or breastfeeding and agree to use one highly effective and one barrier method of contraception, if sexually active, for the duration of the study through 90 days after the last study drug administration. Participants must not donate eggs for the duration of study through 90 days after the last dose of study drug.
✓. Participants capable of producing sperm must agree that they will use one barrier method of contraception and that their partners of childbearing potential will use one highly effective method of contraception for the duration of the study through 90 days after the last study drug administration. Participants must not donate sperm for the duration of study through 90 days after the last dose of study drug.

Exclusion criteria

✕. Have a history of clinically significant hematologic, renal, neurologic, pancreatic, gastrointestinal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, immunological, allergic disease, or other major disorders, as determined by the PI.
✕. Have any surgical or medical condition that could possibly affect drug absorption (including inflammatory bowel disease, history of gastrectomy, cholecystectomy, or other gastrointestinal tract surgery except appendectomy).
✕. Have a current significant medical or psychiatric condition, as determined by the PI.
✕. Have a history of serious adverse reaction or serious hypersensitivity to any drug.
✕. Have, in the opinion of the PI, evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> the upper limit of normal (ULN) or bilirubin \> 1.5 × ULN. Note: Participants with Gilbert syndrome without evidence of hepatic impairment may be enrolled.
✕. Have a history or presence of an abnormal electrocardiogram (ECG), including, but not limited to, complete left bundle branch block, second- or third-degree heart block, evidence of prior myocardial infarction, or any other abnormality that is clinically significant in the PI's opinion or precludes accurate interpretation and calculations of cardiac intervals (e.g., QT, QRS).
✕. Have clinically significant abnormalities, as assessed by the PI, in laboratory tests at the screening and admission visits. Note: Participants may be rescreened at the discretion of the PI with Sponsor approval.
✕. Have abnormal blood pressure: supine systolic blood pressure \< 90 or \> 140 mmHg, supine diastolic blood pressure \< 50 or \> 90 mmHg, pulse rate \< 40 or \> 100 bpm, and body temperature \< 35.4 or \> 37.8 °C (\< 96 or \> 100.3 °F) at the screening and admission visits.

What they're measuring

Number of Participants with Adverse Events

Timeframe: Up to Day 30

Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUCinf)

Timeframe: Up to Day 16

Area Under the Concentration-time Curve from Time 0 to the Last Measurable Concentration (AUClast)

Timeframe: Up to Day 16

Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-dose (AUC0-24)

Timeframe: Up to Day 16

Area Under the Concentration-time Curve Between Consecutive Doses (AUCtau)

Timeframe: Up to Day 16

Maximum Observed Concentration (Cmax)

Timeframe: Up to Day 16

Half-life (t1/2)

Timeframe: Up to Day 16

Time of Maximal Plasma Concentration (tmax)

Timeframe: Up to Day 16