Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05138653 · ClinicalTrials.gov registry record · Phase 1
A Single and Multiple Ascending Dose Trial of CVL-354 in Healthy Participants
A Phase 1 study of Healthy Participants, sponsored by Cerevel Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
- 1
- Study location
NCT05138653: Completed Phase 1 study of Healthy Participants, sponsored by Cerevel Therapeutics.
NCT05138653 is a Phase 1 study of Healthy Participants that has completed, run by Cerevel Therapeutics. The registered enrollment target is 73 participants, above the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (12% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05138653, a Phase 1 study of Healthy Participants, has completed, sponsored by Cerevel Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a 2-part, double-blind, randomized, placebo-controlled, first-in-human trial evaluating a single ascending dose (4-way crossover, Part A) and multiple ascending doses (Part B) of CVL-354.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial treatment, whether or not considered related to the trial treatment. A serious adverse event (SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse event
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CVL-354
Study Locations (1)
Texas
- Labcorp Drug Development - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2021-10-18 |
| Est. Completion | 2023-01-23 |
| Phase | Phase 1 |
What the finished NCT05138653 record still lists
NCT05138653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, above the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (12% higher).
The record links to 1 condition, with Healthy Participants appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05138653 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05138653 about?
NCT05138653 is a clinical study titled "A Single and Multiple Ascending Dose Trial of CVL-354 in Healthy Participants". This is a 2-part, double-blind, randomized, placebo-controlled, first-in-human trial evaluating a single ascending dose (4-way crossover, Part A) and multiple ascending doses (Part B) of CVL-354.
What is the current status of trial NCT05138653?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2021-10-18. Estimated completion is 2023-01-23.
What conditions does trial NCT05138653 study?
This clinical trial studies the following conditions: Healthy Participants.
What interventions are being tested in trial NCT05138653?
The interventions under investigation include: Placebo (DRUG), CVL-354 (DRUG).
Who is sponsoring clinical trial NCT05138653?
This trial is sponsored by Cerevel Therapeutics, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05138653 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Participants
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05138653's enrollment target sits among peer trials
73 33rd of 119 higher than 86 of 119 other Healthy Participants trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Participants trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants
RECRUITING · Phase 1
-
Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers (K-SLEEP)
RECRUITING · Phase 1
-
A Study to Investigate the Concentrations of Zibotentan and Dapagliflozin in Blood When Given With and Without Food
RECRUITING · Phase 1
-
A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants
RECRUITING · Phase 1
-
FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients
RECRUITING · Phase 1
-
A Study to Learn About a Vaccine Against E Coli in Healthy Adults
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03661307 · 73 participants · Phase 1
Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
- NCT05386108 · 73 participants · Phase 1
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
- NCT05961592 · 73 participants · Phase 1
R-2487 in Patients With Rheumatoid Arthritis
- NCT06150664 · 73 participants · Phase 1
A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI