Healthy VolunteersPhase 1NCT03835637
Single and Multiple Dose Study of ORIC-101 in Adult Healthy Subjects
A Phase 1 study testing ORIC-101 in people with Healthy Volunteers, run by ORIC Pharmaceuticals at 1 site in United Kingdom.
Trial summary
This is a single centre, open-label, non-randomised study with up to 2 parts, assessing the safety, tolerability, PK and PD of single (Part A) and multiple (Part B; optional) doses of oral GR antagonist ORIC-101. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ORIC-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Mar 2018to 4 Jul 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males or healthy females of non-child bearing potential
- Age 18 to 65 years of age
- Body mass index of 18.0 to 32.0 kg/m^2 and weight between 50 kg and 120 kg, inclusive
Who cannot join
- Subjects who have received any investigational medicinal product (IMP) in a clinical research study within the previous 3 months
- History of any drug or alcohol abuse in the past 2 years
- Current smokers and those who have smoked within the last 12 months
- Females of childbearing potential
- Women with a history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma
- Current disease requiring treatment with systemic corticosteroids
- Serious adverse reaction or serious hypersensitivity to mifepristone, or any other drug, or the formulation excipients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study of the Oral Glucocorticoid Receptor (GR) Antagonist ORIC-101 in Adult Healthy Subjects
This is a single centre, open-label, non-randomised study with up to 2 parts, assessing the safety, tolerability, PK and PD of single (Part A) and multiple (Part B; optional) doses of oral GR antagonist ORIC-101.
- Conditions
- Healthy Volunteers
- Being tested
- ORIC-101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIC-101Drug
Capsule or oral suspension
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | Not described Receives: Drug: ORIC-101 |
| Regimen B | Experimental | Not described Receives: Drug: ORIC-101 |
| Regimen C | Experimental | Not described Receives: Drug: ORIC-101 |
| Regimen D | Experimental | Not described Receives: Drug: ORIC-101 |
| Regimen F | Experimental | Not described Receives: Drug: ORIC-101 |
| Regimen H | Experimental | Not described Receives: Drug: ORIC-101 |
| Regimen I | Experimental | Not described Receives: Drug: ORIC-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
PK of ORIC-101 as single doses
Measured: 96 hours post-final dose
Area under the curve (AUC)
PK of ORIC-101 as single doses
Measured: 96 hours post-final dose
Number of participants with adverse events
Safety and tolerability of ORIC-101 as single doses
Measured: 96 hours post-final dose
Number of Participants With Abnormal Laboratory Values
Safety and tolerability of ORIC-101 as single doses
Measured: 96 hours post-final dose
Secondary outcomes (6)
Maximum plasma concentration (Cmax)
Comparison of the PK of ORIC-101 in the presence or absence of food
Measured: 96 hours post-final dose
Area under the curve (AUC)
Comparison of the PK of ORIC-101 in the presence or absence of food
Measured: 96 hours post-final dose
Number of participants with adverse events
Safety and tolerability of ORIC-101 as multiple doses
Measured: 96 hours post-final dose
Number of Participants With Abnormal Laboratory Values
Safety and tolerability of ORIC-101 as multiple doses
Measured: 96 hours post-final dose
Maximum plasma concentration (Cmax)
PK of ORIC-101 as multiple doses
Measured: 96 hours post-final dose
Area under the curve (AUC)
PK of ORIC-101 as multiple doses
Measured: 96 hours post-final dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start23 Mar 2018
- Primary completion4 Jul 2018
- Study completion4 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- ORIC Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835637
- Sponsor's protocol ID
- ORIC-GR-17002
- Status last verified
- Feb 2019
- First submitted
- 5 Feb 2019
- Last updated
- 8 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Oral Glucocorticoid Receptor (GR) Antagonist ORIC-101 in Adult Healthy Subjects
- ClinicalTrials.gov ID
- NCT03835637
- Acronym / sponsor ID
- ORIC-GR-17002
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- ORIC PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 4 Jul 2018 (actual)
- First posted
- 8 Feb 2019 (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 a single centre, open-label, non-randomised study with up to 2 parts, assessing the safety, tolerability, PK and PD of single (Part A) and multiple (Part B; optional) doses of oral GR antagonist ORIC-101.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Drug: ORIC-101 |
| Regimen B | Experimental | Drug: ORIC-101 |
| Regimen C | Experimental | Drug: ORIC-101 |
| Regimen D | Experimental | Drug: ORIC-101 |
| Regimen F | Experimental | Drug: ORIC-101 |
| Regimen H | Experimental | Drug: ORIC-101 |
| Regimen I | Experimental | Drug: ORIC-101 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males or healthy females of non-child bearing potential
- Age 18 to 65 years of age
- Body mass index of 18.0 to 32.0 kg/m^2 and weight between 50 kg and 120 kg, inclusive
Key exclusion criteria (7 listed)
- Subjects who have received any investigational medicinal product (IMP) in a clinical research study within the previous 3 months
- History of any drug or alcohol abuse in the past 2 years
- Current smokers and those who have smoked within the last 12 months
- Females of childbearing potential
- Women with a history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma
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 |
|---|---|---|
| ORIC-101Capsule or oral suspension | Drug | Regimen A, Regimen B, Regimen C, Regimen D, Regimen F, Regimen H, Regimen I |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: 96 hours post-final dose
PK of ORIC-101 as single doses
Area under the curve (AUC)
Time frame: 96 hours post-final dose
PK of ORIC-101 as single doses
Number of participants with adverse events
Time frame: 96 hours post-final dose
Safety and tolerability of ORIC-101 as single doses
Number of Participants With Abnormal Laboratory Values
Time frame: 96 hours post-final dose
Safety and tolerability of ORIC-101 as single doses
6 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: 96 hours post-final dose
Area under the curve (AUC)
Time frame: 96 hours post-final dose
Number of participants with adverse events
Time frame: 96 hours post-final dose
Number of Participants With Abnormal Laboratory Values
Time frame: 96 hours post-final dose
Maximum plasma concentration (Cmax)
Time frame: 96 hours post-final dose
Area under the curve (AUC)
Time frame: 96 hours post-final dose
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 8 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ORIC-101 in people with Healthy Volunteers, run by ORIC Pharmaceuticals at 1 site in United Kingdom.
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 3 inclusion and 7 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 8 Feb 2019. 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 Kingdom. 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?
Maximum plasma concentration (Cmax) (time frame: 96 hours post-final dose). The study lists 4 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 8 Feb 2019.