Ulcerative Colitis (UC)Phase 1NCT04254783
A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
A Phase 1 study testing Risankizumab and Cytochrome P450 (CYP) Substrates in people with Ulcerative Colitis (UC) and Crohn's Disease, run by AbbVie at 6 sites in 3 countries.
Trial summary
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis (UC), Crohn's Disease
- What is being tested?
- Risankizumab and Cytochrome P450 (CYP) Substrates
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 27 May 2020to 14 Oct 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of UC or CD for at least 3 months prior to Day -1 (baseline). Appropriate documentation of biopsy results consistent with the diagnosis of CD or UC, in the assessment of the gastroenterologist, must be available.
- Moderately to severely active CD or UC.
- Must have demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates, oral locally acting steroids, systemic steroids, immunomodulators, and/or approved biologic therapies.
- Participant must agree to not use any known inhibitors or inducers of cytochrome P450 within 1 month or 5 half-lives, whichever is greater before each administration of the cocktail probe and until the last pharmacokinetic sample is collected, 7 days after the intake of each probe cocktail.
Who cannot join
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption (e.g., celiac disease, gastroparesis, cholecystectomy, vagotomy).
- Positive for COVID-19 infection signs and symptoms.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
Southern California Res. Ctr. /ID# 216257
Coronado, California, 92118-1408
University Clinical Research /ID# 216823
DeLand, Florida, 32720
Atlantic Medical Research Group /ID# 227465
Margate, Florida, 33063-5737
Clinical Trials of Texas, Inc /ID# 216277
San Antonio, Texas, 78229
Israel1 site
The Chaim Sheba Medical Center /ID# 223959
Ramat Gan, Tel Aviv, 5265601
About this study
Official title: A Phase 1 Study to Evaluate the Effect of Multiple IV Infusions of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates Administered Orally in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study will evaluate the effect of repeated infusions of risankizumab on the pharmacokinetics of sensitive probe substrates of Cytochrome P450 (CYP) enzymes in participants with moderately to severely active UC or CD.
Risankizumab is an investigational drug being developed to treat trial participants with inflammatory diseases such as UC and CD. The study is split into two periods. In Period 1, participants will receive single oral doses of CYP sensitive probes and in Period 2, participants will receive risankizumab followed by single oral doses of CYP sensitive probes. Around 20 adult participants with moderately to severely active CD or UC will be enrolled in the study across multiple sites worldwide.
Read more
In Period 1, participants will receive oral doses of CYP sensitive probes on Day 1. In Period 2, participants will receive risankizumab by intravenous (IV) infusion on Days 1, 29 and 57 followed by oral CYP sensitive probes on Day 64.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.
- Conditions
- Ulcerative Colitis (UC), Crohn's Disease
- Being tested
- Risankizumab, Cytochrome P450 (CYP) Substrates
- Keywords
- Ulcerative Colitis (UC), Crohn's Disease, Risankizumab, SKYRIZI, ABBV-066, Cytochrome P450
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisankizumabDrug
Also called SKYRIZI, ABBV-066
Intravenous (IV) infusion
Cytochrome P450 (CYP) SubstratesDrug
Tablet: Oral; CYP Substrates: midazolam, caffeine, warfarin, vitamin K, omeprazole and metoprolol
| Study group | Role | What they receive |
|---|---|---|
| Cytochrome P450 (CYP) + Risankizumab | Experimental | In Period 1, participants will receive single oral dose of Cytochrome P450 (CYP) substrates on Day 1. In Period 2, three IV doses of risankizumab on Days 1, 29 and 57, followed by single oral dose of CYP substrates on Day 64 will be administered. Receives: Drug: Risankizumab; Drug: Cytochrome P450 (CYP) Substrates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Midazolam
Maximum observed plasma concentration (Cmax) of Midazolam
Measured: Up to 71 Days
Time to Maximum Observed Plasma Concentration (Tmax) of Midazolam
Time to maximum plasma concentration (Tmax) of Midazolam
Measured: Up to 71 Days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Midazolam
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measured: Up to 71 Days
AUC From Time 0 to Infinity (AUCinf) of Midazolam
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measured: Up to 71 Days
Terminal Phase Elimination Rate Constant (β) of Midazolam
Terminal phase elimination rate constant (β) for Midazolam
Measured: Up to 71 Days
Terminal Phase Elimination Half-Life (t1/2) of Midazolam
Terminal phase elimination half-life (t1/2) of Midazolam
Measured: Up to 71 Days
Maximum Observed Plasma Concentration (Cmax) of Caffeine
Maximum observed plasma concentration (Cmax) of Caffeine
Measured: Up to 71 Days
Time to Maximum Observed Plasma Concentration (Tmax) of Caffeine
Time to maximum plasma concentration (Tmax) of Caffeine
Measured: Up to 71 Days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Caffeine
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measured: Up to 71 Days
AUC From Time 0 to Infinity (AUCinf) of Caffeine
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measured: Up to 71 Days
Terminal Phase Elimination Rate Constant (β) of Caffeine
Terminal phase elimination rate constant (β) for Caffeine
Measured: Up to 71 Days
Terminal Phase Elimination Half-Life (t1/2) of Caffeine
Terminal phase elimination half-life (t1/2) of Caffeine
Measured: Up to 71 Days
Maximum Observed Plasma Concentration (Cmax) of Warfarin
Maximum observed plasma concentration (Cmax) of Warfarin
Measured: Up to 71 Days
Time to Maximum Observed Plasma Concentration (Tmax) of Warfarin
Time to maximum plasma concentration (Tmax) of Warfarin
Measured: Up to 71 Days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Warfarin
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measured: Up to 71 Days
AUC From Time 0 to Infinity (AUCinf) of Warfarin
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measured: Up to 71 Days
Terminal Phase Elimination Rate Constant (β) of Warfarin
Terminal phase elimination rate constant (β) for Warfarin
Measured: Up to 71 Days
Terminal Phase Elimination Half-Life (t1/2) of Warfarin
Terminal phase elimination half-life (t1/2) of Warfarin
Measured: Up to 71 Days
Maximum Observed Plasma Concentration (Cmax) of Omeprazole
Maximum observed plasma concentration (Cmax) of Omeprazole
Measured: Up to 71 Days
Time to Maximum Observed Plasma Concentration (Tmax) of Omeprazole
Time to maximum plasma concentration (Tmax) of Omeprazole
Measured: Up to 71 Days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Omeprazole
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measured: Up to 71 Days
AUC From Time 0 to Infinity (AUCinf) of Omeprazole
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measured: Up to 71 Days
Terminal Phase Elimination Rate Constant (β) of Omeprazole
Terminal phase elimination rate constant (β) for Omeprazole
Measured: Up to 71 Days
Terminal Phase Elimination Half-Life (t1/2) of Omeprazole
Terminal phase elimination half-life (t1/2) of Omeprazole
Measured: Up to 71 Days
Maximum Observed Plasma Concentration (Cmax) of Metoprolol
Maximum observed plasma concentration (Cmax) of Metoprolol
Measured: Up to 71 Days
Time to Maximum Observed Plasma Concentration (Tmax) of Metoprolol
Time to maximum plasma concentration (Tmax) of Metoprolol
Measured: Up to 71 Days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Metoprolol
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measured: Up to 71 Days
AUC From Time 0 to Infinity (AUCinf) of Metoprolol
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measured: Up to 71 Days
Terminal Phase Elimination Rate Constant (β) of Metoprolol
Terminal phase elimination rate constant (β) for Metoprolol
Measured: Up to 71 Days
Terminal Phase Elimination Half-Life (t1/2) of Metoprolol
Terminal phase elimination half-life (t1/2) of Metoprolol
Measured: Up to 71 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start27 May 2020
- Primary completion14 Oct 2022
- Study completion14 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254783
- Sponsor's protocol ID
- M19-974
- Other IDs
- 2019-003684-22, 2019
- Status last verified
- Jun 2024
- First submitted
- 3 Feb 2020
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D'Cunha R, Azam T, Kalabic J, Anschutz T, Lahat A, Pang Y. Evaluation of the Effect of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates in Patients with Moderately to Severely Active Ulcerative Colitis or Crohn's Disease. Clin Pharmacokinet. 2025 Jan;64(1):143-154. doi: 10.1007/s40262-024-01462-4. Epub 2024 Dec 21.
PubMed 39707077
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Effect of Multiple IV Infusions of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates Administered Orally in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
- ClinicalTrials.gov ID
- NCT04254783
- Acronym / sponsor ID
- M19-974
- Conditions
- Ulcerative Colitis (UC), Crohn's Disease
- Keywords
- Ulcerative Colitis (UC), Crohn's Disease, Risankizumab, SKYRIZI, ABBV-066, Cytochrome P450
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 27 May 2020 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 5 Feb 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.
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study will evaluate the effect of repeated infusions of risankizumab on the pharmacokinetics of sensitive probe substrates of Cytochrome P450 (CYP) enzymes in participants with moderately to severely active UC or CD.
Risankizumab is an investigational drug being developed to treat trial participants with inflammatory diseases such as UC and CD. The study is split into two periods. In Period 1, participants will receive single oral doses of CYP sensitive probes and in Period 2, participants will receive risankizumab followed by single oral doses of CYP sensitive probes. Around 20 adult participants with moderately to severely active CD or UC will be enrolled in the study across multiple sites worldwide.
In Period 1, participants will receive oral doses of CYP sensitive probes on Day 1. In Period 2, participants will receive risankizumab by intravenous (IV) infusion on Days 1, 29 and 57 followed by oral CYP sensitive probes on Day 64.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cytochrome P450 (CYP) + Risankizumab | Experimental | Drug: Risankizumab, Drug: Cytochrome P450 (CYP) SubstratesIn Period 1, participants will receive single oral dose of Cytochrome P450 (CYP) substrates on Day 1. In Period 2, three IV doses of risankizumab on Days 1, 29 and 57, followed by single oral dose of CYP substrates on Day 64 will be administered. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of UC or CD for at least 3 months prior to Day -1 (baseline). Appropriate documentation of biopsy results consistent with the diagnosis of CD or UC, in the assessment of the gastroenterologist, must be available.
- Moderately to severely active CD or UC.
- Must have demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates, oral locally acting steroids, systemic steroids, immunomodulators, and/or approved biologic therapies.
- Participant must agree to not use any known inhibitors or inducers of cytochrome P450 within 1 month or 5 half-lives, whichever is greater before each administration of the cocktail probe and until the last pharmacokinetic sample is collected, 7 days after the intake of each probe cocktail.
Key exclusion criteria (3 listed)
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption (e.g., celiac disease, gastroparesis, cholecystectomy, vagotomy).
- Positive for COVID-19 infection signs and symptoms.
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 |
|---|---|---|
| RisankizumabAlso: SKYRIZI, ABBV-066Intravenous (IV) infusion | Drug | Cytochrome P450 (CYP) + Risankizumab |
| Cytochrome P450 (CYP) SubstratesTablet: Oral; CYP Substrates: midazolam, caffeine, warfarin, vitamin K, omeprazole and metoprolol | Drug | Cytochrome P450 (CYP) + Risankizumab |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Midazolam
Time frame: Up to 71 Days
Maximum observed plasma concentration (Cmax) of Midazolam
Time to Maximum Observed Plasma Concentration (Tmax) of Midazolam
Time frame: Up to 71 Days
Time to maximum plasma concentration (Tmax) of Midazolam
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Midazolam
Time frame: Up to 71 Days
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
AUC From Time 0 to Infinity (AUCinf) of Midazolam
Time frame: Up to 71 Days
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Terminal Phase Elimination Rate Constant (β) of Midazolam
Time frame: Up to 71 Days
Terminal phase elimination rate constant (β) for Midazolam
Terminal Phase Elimination Half-Life (t1/2) of Midazolam
Time frame: Up to 71 Days
Terminal phase elimination half-life (t1/2) of Midazolam
Maximum Observed Plasma Concentration (Cmax) of Caffeine
Time frame: Up to 71 Days
Maximum observed plasma concentration (Cmax) of Caffeine
Time to Maximum Observed Plasma Concentration (Tmax) of Caffeine
Time frame: Up to 71 Days
Time to maximum plasma concentration (Tmax) of Caffeine
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Caffeine
Time frame: Up to 71 Days
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
AUC From Time 0 to Infinity (AUCinf) of Caffeine
Time frame: Up to 71 Days
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Terminal Phase Elimination Rate Constant (β) of Caffeine
Time frame: Up to 71 Days
Terminal phase elimination rate constant (β) for Caffeine
Terminal Phase Elimination Half-Life (t1/2) of Caffeine
Time frame: Up to 71 Days
Terminal phase elimination half-life (t1/2) of Caffeine
Maximum Observed Plasma Concentration (Cmax) of Warfarin
Time frame: Up to 71 Days
Maximum observed plasma concentration (Cmax) of Warfarin
Time to Maximum Observed Plasma Concentration (Tmax) of Warfarin
Time frame: Up to 71 Days
Time to maximum plasma concentration (Tmax) of Warfarin
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Warfarin
Time frame: Up to 71 Days
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
AUC From Time 0 to Infinity (AUCinf) of Warfarin
Time frame: Up to 71 Days
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Terminal Phase Elimination Rate Constant (β) of Warfarin
Time frame: Up to 71 Days
Terminal phase elimination rate constant (β) for Warfarin
Terminal Phase Elimination Half-Life (t1/2) of Warfarin
Time frame: Up to 71 Days
Terminal phase elimination half-life (t1/2) of Warfarin
Maximum Observed Plasma Concentration (Cmax) of Omeprazole
Time frame: Up to 71 Days
Maximum observed plasma concentration (Cmax) of Omeprazole
Time to Maximum Observed Plasma Concentration (Tmax) of Omeprazole
Time frame: Up to 71 Days
Time to maximum plasma concentration (Tmax) of Omeprazole
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Omeprazole
Time frame: Up to 71 Days
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
AUC From Time 0 to Infinity (AUCinf) of Omeprazole
Time frame: Up to 71 Days
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Terminal Phase Elimination Rate Constant (β) of Omeprazole
Time frame: Up to 71 Days
Terminal phase elimination rate constant (β) for Omeprazole
Terminal Phase Elimination Half-Life (t1/2) of Omeprazole
Time frame: Up to 71 Days
Terminal phase elimination half-life (t1/2) of Omeprazole
Maximum Observed Plasma Concentration (Cmax) of Metoprolol
Time frame: Up to 71 Days
Maximum observed plasma concentration (Cmax) of Metoprolol
Time to Maximum Observed Plasma Concentration (Tmax) of Metoprolol
Time frame: Up to 71 Days
Time to maximum plasma concentration (Tmax) of Metoprolol
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Metoprolol
Time frame: Up to 71 Days
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
AUC From Time 0 to Infinity (AUCinf) of Metoprolol
Time frame: Up to 71 Days
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Terminal Phase Elimination Rate Constant (β) of Metoprolol
Time frame: Up to 71 Days
Terminal phase elimination rate constant (β) for Metoprolol
Terminal Phase Elimination Half-Life (t1/2) of Metoprolol
Time frame: Up to 71 Days
Terminal phase elimination half-life (t1/2) of Metoprolol
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 1 Jul 2024.
- Derived from this study: PubMed 39707077D'Cunha R, Azam T, Kalabic J, Anschutz T, Lahat A, Pang Y. Evaluation of the Effect of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates in Patients with Moderately to Severely Active Ulcerative Colitis or Crohn's Disease. Clin Pharmacokinet. 2025 Jan;64(1):143-154. doi: 10.1007/s40262-024-01462-4. Epub 2024 Dec 21.
- Individual participant dataSharing planned: No
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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.
ABBVIE INC. study director
AbbVie
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Risankizumab and Cytochrome P450 (CYP) Substrates in people with Ulcerative Colitis (UC) and Crohn's Disease, run by AbbVie at 6 sites in 3 countries.
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 3 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 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Germany, Israel. 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 Observed Plasma Concentration (Cmax) of Midazolam (time frame: Up to 71 Days). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04254783, which also lists 1 linked publication.
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 1 Jul 2024.