PharmacokineticPhase 1NCT04531150
Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects
A Phase 1 study testing INV-101 in people with Pharmacokinetic, run by Inversago Pharma Inc. at 1 site in Canada.
Trial summary
Single center, randomized, double-blinded, placebo-controlled, single ascending-dose study for the evaluation of the safety, tolerability, and PK following single oral doses of INV-101. Read more about this study
- Who is it for?
- Ages 15 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic
- What is being tested?
- INV-101
- 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 siteCanada
- Study dates
- 8 Sep 2020to 16 May 2021
- 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 15 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy adult male or female
- Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively; and body weight ≥60 kg
- Non- or ex-smoker
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator
Who cannot join
- Female who is pregnant or lactating
- Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment (maximum QTc of 450 for males and 470 for females)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Phase I, Double-Blind, Placebo-Controlled Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects
Single center, randomized, double-blinded, placebo-controlled, single ascending-dose study for the evaluation of the safety, tolerability, and PK following single oral doses of INV-101.
- Conditions
- Pharmacokinetic
- Being tested
- INV-101, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INV-101Drug
Subjects will be randomized to receive INV-101 tablets
PlaceboDrug
Subjects will be randomized to receive placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subjects will be randomized to receive either placebo or 20 mg INV-101 Receives: Drug: INV-101; Drug: Placebo |
| Cohort 2 | Experimental | Subjects will be randomized to receive either placebo or 80 mg INV-101 Receives: Drug: INV-101; Drug: Placebo |
| Cohort 3 | Experimental | Subjects will be randomized to receive either placebo or 160 mg INV-101 Receives: Drug: INV-101; Drug: Placebo |
| Cohort 4 | Experimental | Subjects will be randomized to receive either placebo or 320 mg INV-101 Receives: Drug: INV-101; Drug: Placebo |
| Cohort 5 | Experimental | Subjects will be randomized to receive either placebo or 500 mg INV-101 Receives: Drug: INV-101; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters - Maximum Concentration (Cmax)
Cmax following single dose
Measured: 72 hours
Pharmacokinetic parameters - AUC
AUC following single dose
Measured: 72 hours
Pharmacokinetic parameters - Half-live
Half-live following single dose
Measured: 72 hours
Secondary outcomes (1)
Adverse events
Safety of INV-101 following single dose
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start8 Sep 2020
- Primary completion16 Jan 2021
- Study completion16 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inversago Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531150
- Sponsor's protocol ID
- INV101-CL-101
- Status last verified
- Mar 2025
- First submitted
- 24 Aug 2020
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Phase I, Double-Blind, Placebo-Controlled Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT04531150
- Acronym / sponsor ID
- INV101-CL-101
- Conditions
- Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Inversago Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 16 Jan 2021 (actual)
- Study completion
- 16 May 2021 (actual)
- First posted
- 28 Aug 2020 (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.
Single center, randomized, double-blinded, placebo-controlled, single ascending-dose study for the evaluation of the safety, tolerability, and PK following single oral doses of INV-101.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: INV-101, Drug: PlaceboSubjects will be randomized to receive either placebo or 20 mg INV-101 |
| Cohort 2 | Experimental | Drug: INV-101, Drug: PlaceboSubjects will be randomized to receive either placebo or 80 mg INV-101 |
| Cohort 3 | Experimental | Drug: INV-101, Drug: PlaceboSubjects will be randomized to receive either placebo or 160 mg INV-101 |
| Cohort 4 | Experimental | Drug: INV-101, Drug: PlaceboSubjects will be randomized to receive either placebo or 320 mg INV-101 |
| Cohort 5 | Experimental | Drug: INV-101, Drug: PlaceboSubjects will be randomized to receive either placebo or 500 mg INV-101 |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Healthy adult male or female
- Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively; and body weight ≥60 kg
- Non- or ex-smoker
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator
Key exclusion criteria (4 listed)
- Female who is pregnant or lactating
- Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment (maximum QTc of 450 for males and 470 for females)
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 |
|---|---|---|
| INV-101Subjects will be randomized to receive INV-101 tablets | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| PlaceboSubjects will be randomized to receive placebo tablets | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Pharmacokinetic parameters - Maximum Concentration (Cmax)
Time frame: 72 hours
Cmax following single dose
Pharmacokinetic parameters - AUC
Time frame: 72 hours
AUC following single dose
Pharmacokinetic parameters - Half-live
Time frame: 72 hours
Half-live following single dose
1 secondary outcome
Adverse events
Time frame: 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 Mar 2025.
- Individual participant dataSharing planned: No
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Healthy Participants
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.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
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 INV-101 in people with Pharmacokinetic, run by Inversago Pharma Inc. at 1 site in Canada.
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 4 inclusion and 4 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 Mar 2025. 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 Canada. 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. 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?
Pharmacokinetic parameters - Maximum Concentration (Cmax) (time frame: 72 hours). The study lists 3 primary outcomes in all. 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 Mar 2025.