Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vardenafil · 1 trial · 1 indication
Adverse events reported by participants and those observed by the investigator in relation to laboratory tests, vital signs, ECGs, medications used to treat adverse events, and physical examinations were analyzed.
| Arm | Type | Description |
|---|---|---|
| RT234 0.2 mg, Single Ascending Dose (SAD) | EXPERIMENTAL | Part 1, SAD Cohort 1A |
| RT234 0.6 mg followed by oral vardenafil 20mg on day 3, SAD | EXPERIMENTAL | Part 1, SAD Cohort 2A1 |
| Oral vardenafil 20mg followed by RT234 0.6 mg on day 3, SAD | EXPERIMENTAL | Part 1, SAD Cohort 2A2 |
| RT234 1.2 mg, SAD | EXPERIMENTAL | Part 1, SAD Cohort 3A |
| RT234 2.4 mg, SAD | EXPERIMENTAL | Part 1, SAD Cohort 4A |
| RT234 2.4 mg, Multiple Ascending Dose (MAD) | EXPERIMENTAL | Part 2, MAD Cohort 1B |
| Name | Type | Description |
|---|---|---|
| Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI) | COMBINATION_PRODUCT | RT234 is a drug/device combination product composed of vardenafil hydrochloride as the drug constituent and will utilize RS01 DPI device. |
| Vardenafil Oral Tablet | DRUG | 20 mg oral vardenafil tablet. |
Inclusion Criteria: 1. Healthy male or female, 18 to 45 years of age (inclusive at time of informed consent) 2. Normal heart, lung, kidney, and liver function based on physical examination 3. Systolic blood pressure of 100-145 mmHg, diastolic blood pressure of 50-90 mmHg, and a resting heart rate o...
Vardenafil is a small molecule drug being developed by Gossamer Bio, Inc. (GOSS). It is currently in Phase 1 clinical development for use in healthy volunteers. The drug has been studied in a completed clinical trial.
Vardenafil is being investigated for use in healthy volunteers. It is currently in Phase 1 clinical development, meaning it is an investigational drug that has not yet been approved for any medical condition.
Vardenafil is being developed by Gossamer Bio, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol GOSS. The company is conducting clinical trials to evaluate the drug's safety and tolerability.
Vardenafil is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety, tolerability, and pharmacokinetics.
Vardenafil has been studied in one completed Phase 1 clinical trial, identified as NCT05567367. This trial evaluated the safety, tolerability, and pharmacokinetics of the drug in healthy volunteers in Australia, enrolling 31 participants.
Vardenafil is the drug being studied in the clinical trial NCT05567367, which is titled 'A Healthy Volunteer Study Evaluating the Safety, Tolerability, and Pharmacokinetics of RT234'. This indicates that RT234 is the investigational name used for Vardenafil in this study.