Phase 1
N=6
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04036227 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Number of Treatment Related Adverse Events — 3; 4; 0; 3 Number of events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- GS-248 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gesynta Pharma AB
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment Related Adverse Events |
3; 4; 0; 3; 2; 1 | — |
| PRIMARY Clinically Significant Changes in ECG |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Clinically Significant Changes in Vital Signs |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Clinically Significant Changes in Safety Laboratory Parameters |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Clinically Significant Changes in Physical Examination |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Cmax: |
1.247; 8.975; 11.82; 145.3; 263.3; 818.3 | — |
| SECONDARY Tmax: |
1.500; 2.500; 1.000; 1.000; 1.000; 1.500 | — |
| SECONDARY T½: |
4.539; 1.089; 1.660; 9.220; 9.513; 11.14 | — |
| SECONDARY AUC0-t: |
2.437; 30.57; 39.08; 478.6; 879.8; 2667 | — |
| SECONDARY AUC 0-inf |
8.542; 40.22; 41.77; 489.3; 894.7; 2713 | — |
| SECONDARY AUCss |
205.9; 604.6; 4046 | — |
| SECONDARY Clearance (CL)/F: |
173.7; 228.2; 304.8; 161.4; 184.8; 318.2 | — |
| SECONDARY Vz/F: |
1097; 341.9; 719.7; 2117; 2378; 4856 | — |
| SECONDARY Accumulation Ratio AUC 0-ss |
1.148; 1.171; 2.390 | — |
Summary
This is a First in Human (FIH), double-blinded, parallel-group, randomised, placebo-controlled study designed to evaluate the safety, tolerability, PK and PD of single and multiple ascending oral doses of GS-248 in healthy subjects.
Eligibility Criteria
Inclusion Criteria
- Willing and able to give written informed consent for participation in the study.
- Male and female healthy subjects aged 18-70 years inclusive (Part I [SAD]) and 40-75 years inclusive (Part II [MAD])
- Women of child bearing potential must practice abstinence or must agree to use a highly effective method of contraception with a failure rate of 140 mmHg, or
- Diastolic blood pressure 90 mmHg, or
- Pulse 90 bpm
- Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV) 1 and/or 2 antibodies at screening.
- Presence or history of drug and/or alcohol abuse and/or excessive intake of alcohol and/or history, or current use, of anabolic steroids, as judged by the Investigator.
- Any positive result for drug abuse and/or alcohol at screening or on admission to the unit prior to administration of the IMP.
- Participation in another clinical study with an experimental drug within 3 months before the administration of IMP.
- Consumption of grapefruit or grapefruit juice within 14 days of study drug administration.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma or resected benign colonic polyps.
- Any planned major surgery within the duration of the study.
- Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g. smoking, snuffing, chewing tobacco) less than 3 times per week is allowed before screening visit.
- Regular excessive caffeine consumption defined by a daily intake of >5 cups of caffeine containing beverages.
- Intake of xanthine and/or taurine containing energy drinks within 2 days prior to screening.
- Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.
- Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
Data sourced from ClinicalTrials.gov (NCT04036227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.