Phase I Study of Progerinin in Healthy Volunteers (NCT04512963) | Clinical Trial Compass
CompletedPhase 1
Phase I Study of Progerinin in Healthy Volunteers
United States64 participantsStarted 2020-08-24
Plain-language summary
PRG-PRO-001 is a Phase I, Randomized, Double-blind, Placebo-Controlled, Single Ascending Dose (SAD) Study including a food interaction study, followed by a Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Profile of Progerinin in Healthy Volunteers. This is a first-in-human study. The study aims to determine the safety and tolerability of Progerinin after single and multiple doses in healthy volunteers and to evaluate the pharmacokinetics (PK) of Progerinin after single and multiple dose administrations in healthy volunteers.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Healthy male and female subjects, 18 to 45 years of age, inclusive.
✓. The subject has a body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, and weighs at least 50 kg.
✓. The subject is in good health and has no medical condition of clinical significance or that may impact the outcome of the study, as determined by the investigator (as determined by medical history, physical examination, 12-lead electrocardiogram \[ECG\], vital signs, and clinical laboratory results at screening).
✓. The subject is able to understand the nature of the study and any potential hazards associated with participating in it.
✓. The subject is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study.
✓. The subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided, and has had the opportunity to discuss the study with the investigator or designee.
✓. Negative pregnancy test for female subjects. Women of child bearing potential (WOCBP) and Women not of child bearing potential are eligible to participate. Both women of child bearing potential and women of no child bearing potential should use an approved method of birth control and agrees to continue to use this method for the duration of the study (and for 90 days after taking the last dose of Progerinin).
What they're measuring
1
Incidence of Dose Limiting Toxicities (DLTs)
Timeframe: Day 1 through 7 days after the last study drug administration
2
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Day 1 through 7 days after the last study drug administration
3
Incidence of withdrawals due to Adverse Events (AEs)
Timeframe: Day 1 through 7 days after the last study drug administration
4
Incidence of abnormal blood work tests results, abnormal Urinalysis and positive Pregnancy test
Timeframe: At baseline, 72 to 96 hours after the last study drug administration, and on Day 7 after the first and the last study drug administration
5
Change in vital signs
Timeframe: At pre-dose, over 96 hours after study drug administration, and on Day 7 after the last study drug administration
6
Incidence of abnormal ECG parameters
Timeframe: At pre-dose, over 96 hours after study drug administration, and on Day 7 after the last study drug administration
7
Incidence of abnormal physical examination findings
Timeframe: At baseline, 96 hours after the last study drug administration, and on Day 7 after the last study drug administration
✓. Subjects not taking any medications or dietary supplements (i.e., St. John's Wort and goldenseal) which are inhibitors or inducers of CYP 3A4 and CYP 2D6 during screening and for the duration of the trial.
Exclusion criteria
✕. The subject has a history of severe allergic or anaphylactic reactions.
✕. The subject has a known allergy or hypersensitivity to any component of the formulation.
✕. The subject has a medical history or current evidence of any clinically significant (as determined by the investigator) cardiac, endocrine (including diabetes), hematologic, hepatobiliary (abnormal 12lanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], gamma-glutamyl transpeptidase \[GGT\], or total bilirubin), immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal condition, or other major disease.
✕. The subject has a history of any malignant disease.
✕. The subject has a history of more than one herpes zoster episode or multimetameric herpes zoster.
✕. The subject has a history of an opportunistic infection (e.g. cytomegalovirus, pneumocystis carinii, aspergillosis, clostridium difficile).
✕. The subject has a history of or ongoing chronic or recurrent infectious disease (e.g. infected indwelling prosthesis, osteomyelitis, chronic sinusitis).
✕. The subject has had major trauma or surgery in the 2 months before screening or at any time between screening and check-in.
8
Maximum observed plasma drug concentration (Cmax)
Timeframe: 0-96 hours
9
Apparent terminal elimination half-life (t1/2)
Timeframe: 0-96 hours
10
Time to maximum observed plasma drug concentration (Tmax)
Timeframe: 0-96 hours
11
Area under the plasma drug concentration-time curve (AUC)
Timeframe: 0-96 hours
12
Percentage of AUC0-∞ extrapolated from Tlast to infinity (AUCext)