PsoriasisPhase 1NCT03724292
An Ascending Multiple Dose Study With VTP-43742 in Healthy Volunteers
A Phase 1 study testing VTP-43742 in people with Psoriasis, run by Vitae Pharmaceuticals Inc., an Allergan affiliate at 1 site in United States.
Trial summary
This is Part 1 of a two-part, randomized, double-blind, placebo-controlled study in which VTP-43742 was administered to participants; Part 1 in healthy volunteers and Part 2 in psoriatic participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- VTP-43742
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2015to 8 Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females, 18 to 45 years of age, inclusive.
- Body weight of at least 55 kg and body mass index of 18-32 kg/m2, inclusive.
- Medically healthy with clinically insignificant screening results.
- Women of child-bearing potential (WOCBP) AND men with partners who are WOCBP must agree that they and/or their partner will use two reliable forms of contraception as per study requirements
- WOCBP must have a negative serum β-hCG pregnancy test at the Screening and Baseline visit.
- Voluntarily consent to participate in the trial
Who cannot join
- Unwilling or unable to provide written informed consent
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, coagulation, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- Evidence of organ dysfunction or any clinically significant deviation from normal in vital signs, physical examination, clinical laboratory determinations or ECG
- Any major surgery within 3 months of Screening
- Positive urine drug/alcohol testing at Screening or Baseline visit
- Use of tobacco and/or nicotine-containing products within 3 months prior to the start of dosing of the trial
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- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV Ab) at Screening
- History or presence of alcoholism or drug abuse as defined in DSM V, Diagnostic Criteria for Drug and Alcohol Abuse
- History of hypersensitivity or idiosyncratic reaction to drugs from multiple drug classes
- Any previous gastrointestinal surgery or recent (within 3 months) history of gastrointestinal disease that could impact the absorption of the study drug
- Blood donation or significant blood loss within 8 weeks prior to Day 1 of the trial
- Plasma donation within 7 days prior to Day 1 of the trial
- Blood transfusion within 4 weeks of Screening
- Positive serum pregnancy test (WOCBP) at the Screening or Baseline visit
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical disease (e.g., infectious disease) must not be enrolled into this study
- Any other medical, psychiatric, and/or social reason as determined by the Investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Volunteer Site 1
Fair Lawn, New Jersey, 07410
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Ascending Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VTP-43742 in Healthy Volunteers and Proof-of-Concept in Psoriatic Patients
This is Part 1 of a two-part, randomized, double-blind, placebo-controlled study in which VTP-43742 was administered to participants; Part 1 in healthy volunteers and Part 2 in psoriatic participants.
Read the detailed description
This was a prospective, randomized, double-blind, placebo-controlled, ascending multiple dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics effects of VTP-43742 in healthy volunteers conducted at a single, study center in the United States (Part 1). A total of 74 participants were enrolled both parts of the study (Part 1 with 40 healthy subjects; Part 2 with 34 psoriatic participants). This post includes data from Part 1 of the study only; Part 2 is reported separately.
- Conditions
- Psoriasis
- Being tested
- Placebo, VTP-43742
- Keywords
- Moderate to severe chronic plaque-type psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Dose-matched placebo administered as oral capsule(s) once daily
VTP-43742Drug
VTP-43742 administered as oral capsule(s) once daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Dose-matched placebo administered as oral capsule(s) once daily Receives: Drug: Placebo |
| VTP-43742 Dose 1 | Experimental | VTP-43742 administered as oral capsule(s) once daily Receives: Drug: VTP-43742 |
| VTP-43742 Dose 2 | Experimental | VTP-43742 administered as oral capsule(s) once daily Receives: Drug: VTP-43742 |
| VTP-43742 Dose 3 | Experimental | VTP-43742 administered as oral capsule(s) once daily Receives: Drug: VTP-43742 |
| VTP-43742 Dose 4 | Experimental | VTP-43742 administered as oral capsule(s) once daily Receives: Drug: VTP-43742 |
| VTP-43742 Dose 5 | Experimental | VTP-43742 administered as oral capsule(s) once daily Receives: Drug: VTP-43742 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs) in the healthy volunteer (Part 1) group
Measured: Study Day 1 to Day 17±2 (follow up)
Secondary outcomes (4)
Maximum plasma concentration (Cmax) in the healthy volunteer (Part 1) group
Measured: Day 1 and Day 10
Time to maximum plasma concentrations (tmax) in the healthy volunteer (Part 1) group
Measured: Day 1 and Day 10
The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration (AUCt) in the healthy volunteer (Part 1) group
Measured: Day 1 and Day 10
Half life (t½) in the healthy volunteer (Part 1) group
Measured: Day 10 to Day 13 (72 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start1 Aug 2015
- Primary completion8 Mar 2016
- Study completion8 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitae Pharmaceuticals Inc., an Allergan affiliate
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Gregg, MD, Study director, Vitae Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724292
- Sponsor's protocol ID
- VTP-43742-002-1
- Status last verified
- Oct 2018
- First submitted
- 26 Oct 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Ascending Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VTP-43742 in Healthy Volunteers and Proof-of-Concept in Psoriatic Patients
- ClinicalTrials.gov ID
- NCT03724292
- Acronym / sponsor ID
- VTP-43742-002-1
- Conditions
- Psoriasis
- Keywords
- Moderate to severe chronic plaque-type psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vitae Pharmaceuticals Inc., an Allergan affiliateIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 8 Mar 2016 (actual)
- Study completion
- 8 Mar 2016 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is Part 1 of a two-part, randomized, double-blind, placebo-controlled study in which VTP-43742 was administered to participants; Part 1 in healthy volunteers and Part 2 in psoriatic participants.
Detailed description
This was a prospective, randomized, double-blind, placebo-controlled, ascending multiple dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics effects of VTP-43742 in healthy volunteers conducted at a single, study center in the United States (Part 1). A total of 74 participants were enrolled both parts of the study (Part 1 with 40 healthy subjects; Part 2 with 34 psoriatic participants). This post includes data from Part 1 of the study only; Part 2 is reported separately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboDose-matched placebo administered as oral capsule(s) once daily |
| VTP-43742 Dose 1 | Experimental | Drug: VTP-43742VTP-43742 administered as oral capsule(s) once daily |
| VTP-43742 Dose 2 | Experimental | Drug: VTP-43742VTP-43742 administered as oral capsule(s) once daily |
| VTP-43742 Dose 3 | Experimental | Drug: VTP-43742VTP-43742 administered as oral capsule(s) once daily |
| VTP-43742 Dose 4 | Experimental | Drug: VTP-43742VTP-43742 administered as oral capsule(s) once daily |
| VTP-43742 Dose 5 | Experimental | Drug: VTP-43742VTP-43742 administered as oral capsule(s) once daily |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males or females, 18 to 45 years of age, inclusive.
- Body weight of at least 55 kg and body mass index of 18-32 kg/m2, inclusive.
- Medically healthy with clinically insignificant screening results.
- Women of child-bearing potential (WOCBP) AND men with partners who are WOCBP must agree that they and/or their partner will use two reliable forms of contraception as per study requirements
- WOCBP must have a negative serum β-hCG pregnancy test at the Screening and Baseline visit.
Key exclusion criteria (16 listed)
- Unwilling or unable to provide written informed consent
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, coagulation, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- Evidence of organ dysfunction or any clinically significant deviation from normal in vital signs, physical examination, clinical laboratory determinations or ECG
- Any major surgery within 3 months of Screening
- Positive urine drug/alcohol testing at Screening or Baseline visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboDose-matched placebo administered as oral capsule(s) once daily | Drug | Placebo |
| VTP-43742VTP-43742 administered as oral capsule(s) once daily | Drug | VTP-43742 Dose 1, VTP-43742 Dose 2, VTP-43742 Dose 3, VTP-43742 Dose 4, VTP-43742 Dose 5 |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs) in the healthy volunteer (Part 1) group
Time frame: Study Day 1 to Day 17±2 (follow up)
4 secondary outcomes
Maximum plasma concentration (Cmax) in the healthy volunteer (Part 1) group
Time frame: Day 1 and Day 10
Time to maximum plasma concentrations (tmax) in the healthy volunteer (Part 1) group
Time frame: Day 1 and Day 10
The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration (AUCt) in the healthy volunteer (Part 1) group
Time frame: Day 1 and Day 10
Half life (t½) in the healthy volunteer (Part 1) group
Time frame: Day 10 to Day 13 (72 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Gregg, MD study director
Vitae Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VTP-43742 in people with Psoriasis, run by Vitae Pharmaceuticals Inc., an Allergan affiliate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (TEAEs) in the healthy volunteer (Part 1) group (time frame: Study Day 1 to Day 17±2 (follow up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.