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NUV001 for Healthy Subjects

Phase 1
Waitlist Available
Led By Mary Beth Brune, MD
Research Sponsored by Nuvamid SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-smoker and no use of tobacco or nicotine-containing products for 6 months prior to screening
Body weight between 60 kg and 100 kg for males, and 50 kg and 100 kg for females
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment period 1 (sad) : predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after dosing on day 1; treatment period 2 (mad) : predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after dosing on days 1 and 14 and predose on days 4, 8 and 12
Awards & highlights

Study Summary

This trial will test a new drug to see how safe and well-tolerated it is, and how it affects the body over time.

Who is the study for?
Healthy adults aged 18-55, with a BMI of 18-30 kg/m² and weight limits (60-100 kg for males, 50-100 kg for females). Participants must be non-smokers, not using nicotine products for the past 6 months, likely to follow study procedures, and if capable of childbearing, agree to use effective contraception. Males with partners who can bear children must also practice birth control.Check my eligibility
What is being tested?
This trial is testing NUV001 in various doses compared to a placebo in healthy people. It's blinded so participants won't know if they're getting the real drug or a fake one. The goal is to check how safe it is and how the body processes it after one dose or several over time.See study design
What are the potential side effects?
Since this trial aims at determining safety and tolerability of NUV001 in humans for the first time, potential side effects are unknown but will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't smoked or used nicotine products for at least 6 months.
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My weight is within the required range for my gender.
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My recent health checks and heart tests show I am healthy.
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I am not under legal supervision or control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment period 1 (sad) : predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after dosing on day 1; treatment period 2 (mad) : predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after dosing on days 1 and 14 and predose on days 4, 8 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment period 1 (sad) : predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after dosing on day 1; treatment period 2 (mad) : predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after dosing on days 1 and 14 and predose on days 4, 8 and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety as measured by subject incidence of treatment-emergent adverse events (SAD/MAD)
Safety as measured by subject incidence of treatment-emergent clinically significant changes in Blood safety tests (SAD/MAD)
Safety as measured by subject incidence of treatment-emergent clinically significant changes in Electrocardiograms (SAD/MAD)
+3 more
Secondary outcome measures
NUV001 concentration in whole blood (SAD/MAD)
NUV001 metabolite A concentration in whole blood (SAD/MAD)
NUV001 metabolite B concentration in plasma (SAD/MAD)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NUV001 activeExperimental Treatment4 Interventions
Single oral administration (treatment period 1 - SAD) and after a washout of at least 5 days, repeated once daily (q.d.) administrations for 14 days (treatment period 2 - MAD)
Group II: NUV001 PlaceboPlacebo Group4 Interventions
Single oral administration (treatment period 1 - SAD) and after a washout of at least 5 days, repeated once daily (q.d.) administrations for 14 days (treatment period 2 - MAD)

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AnapharmIndustry Sponsor
10 Previous Clinical Trials
365 Total Patients Enrolled
Nuvamid SALead Sponsor
Medpace, Inc.Industry Sponsor
94 Previous Clinical Trials
29,583 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for participation in this trial beyond 45 years?

"This experimental trial has set the age limit for participants between 18 and 55, in line with its inclusion criteria."

Answered by AI

What is the fundamental purpose of this clinical experiment?

"The main purpose of this trial, which will last from the first admission to discharge plus 10 days for follow up visits, is measuring patient safety as indicated by weight changes. Additionally, secondary goals include monitoring and tracking NUV001 metabolites C in urine, A in whole blood, and B in plasma throughout the experiment."

Answered by AI

Which individuals are being considered for this clinical investigation?

"Eligible participants for this trial must be between 18 and 55 years old, with no major medical conditions. A maximum of 32 people will be selected to participate in the study."

Answered by AI

Are there any vacancies left for participants in this research project?

"The clinicaltrials.gov database stipulates that this trial, which was originally posted on November 27th 2023 and last updated on November 10th 2023 is not currently looking for applicants. However, 844 other trials are actively recruiting participants right now."

Answered by AI

Has the FDA granted approval to NUV001 for medical use?

"NUV001 active has a safety score of 1 due to the limited evidence backing its efficacy, as this is only at Phase 1 trial stage."

Answered by AI

Who else is applying?

What site did they apply to?
Medpace Clinical Pharmacology Unit
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Just wanted to help science.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Study of the Safety, Tolerability, and Pharmacokinetics of NUV001 Administered Orally to Healthy Adult Participants
2023. "Study of the Safety, Tolerability, and Pharmacokinetics of NUV001 Administered Orally to Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06133478.
~21 spots leftby Apr 2025
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