Healthy SubjectsPhase 1NCT01561963

A Drug-Drug Interaction Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Apremilast

A Phase 1 study testing Apremilast, Rifampin Oral Capsules and Rifampin IV Solution in people with Healthy Subjects, run by Amgen at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate how the pharmacokinetics of apremilast may be affected by a single intravenous dose of rifampin and multiple oral doses of rifampin. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Apremilast, Rifampin Oral Capsules and Rifampin IV Solution
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2012to 1 Apr 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male or female subjects of any ethnic origin between ages of 18 and 55 with a body mass index between 18 and 33

Who cannot join

Recent history (i.e., within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, allergic or other major disorders.
Use of any prescribed or non-prescribed systemic or topical medication (including vitamins and herbal medicines, e.g. St. John's Wort) within 30 days of the first dose, unless an exception is granted by the sponsor.
Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, or plans to have elective or medical procedures during the conduct of the trial.
Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration

Trial locations and contacts

1 site in 1 country.

United States1 site

Quintiles
Overland Park, Kansas, 66211

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Three-period, Fixed-sequence Study to Evaluate the Effects of Rifampin on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Subjects

The purpose of this study is to evaluate how the pharmacokinetics of apremilast may be affected by a single intravenous dose of rifampin and multiple oral doses of rifampin.

Conditions: Healthy Subjects
Being tested: Apremilast, Rifampin Oral Capsules, Rifampin IV Solution
Keywords: Apremilast, drug interaction, pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ApremilastDrug
Also called CC-10004, Otezla®
Tablets for oral administration
Rifampin Oral CapsulesDrug
Also called RIFADIN™
Capsules for oral administration
Rifampin IV SolutionDrug
Also called RIFADIN™
Intravenous (IV) solution

Study groups in NCT01561963
Study group	Role	What they receive
Apremilast and Rifampin	Experimental	Participants received the following 3 treatment regimens: * A single oral dose of 30 mg apremilast on Day 1 (Period 1); * A single oral dose of 30 mg apremilast followed 5 minutes later by a 30-minute intravenous infusion of 600 mg rifampin on Day 5 (Period 2); * Once daily oral doses of 600 mg rifampin for 15 days (from Day 7 to Day 21) with a single oral dose of 30 mg apremilast co-administered with the rifampin dose on Day 20 (Period 3). Receives: Drug: Apremilast; Drug: Rifampin Oral Capsules; Drug: Rifampin IV Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUCt) of Apremilast
Plasma concentrations of apremilast were determined by means of a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometric (LC-MS/MS) assay.
Measured: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC∞) of Apremilast
Plasma concentrations of apremilast were determined by means of a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometric (LC-MS/MS) assay.
Measured: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20
Maximum Observed Plasma Concentration (Cmax) of Apremilast
Plasma concentrations of apremilast were determined by means of a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometric (LC-MS/MS) assay.
Measured: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20
Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast
Plasma concentrations of apremilast were determined by means of a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometric (LC-MS/MS) assay.
Measured: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20
Estimate of the Terminal Elimination Half-life (T1/2) of Apremilast in Plasma
Plasma concentrations of apremilast were determined by means of a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometric (LC-MS/MS) assay.
Measured: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20
Apparent Total Plasma Clearance (CL/F) of Apremilast
Plasma concentrations of apremilast were determined by means of a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometric (LC-MS/MS) assay.
Measured: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20
Apparent Volume of Distribution (Vz/F) of Apremilast
Plasma concentrations of apremilast were determined by means of a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometric (LC-MS/MS) assay.
Measured: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20121 Apr 2012

First posted23 Mar 2012 (estimated)
Study start1 Feb 2012
Primary completion1 Apr 2012
Study completion1 Apr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy SubjectsStudies of the same condition, open and under way.
More trials run by AmgenThe 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01561963
Sponsor's protocol ID: CC-10004-CP-025
Status last verified: May 2021
First submitted: 21 Mar 2012
Last updated: 9 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Publications

Liu Y, Zhou S, Wan Y, Wu A, Palmisano M. The impact of co-administration of ketoconazole and rifampicin on the pharmacokinetics of apremilast in healthy volunteers. Br J Clin Pharmacol. 2014 Nov;78(5):1050-7. doi: 10.1111/bcp.12448.
PubMed 24962564

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy Subjects trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Three-period, Fixed-sequence Study to Evaluate the Effects of Rifampin on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Subjects
ClinicalTrials.gov ID: NCT01561963
Acronym / sponsor ID: CC-10004-CP-025
Conditions: Healthy Subjects
Keywords: Apremilast, drug interaction, pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 1 Feb 2012 (actual)
Primary completion: 1 Apr 2012 (actual)
Study completion: 1 Apr 2012 (actual)
First posted: 23 Mar 2012 (estimated)
Results: Posted 9 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate how the pharmacokinetics of apremilast may be affected by a single intravenous dose of rifampin and multiple oral doses of rifampin.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Apremilast and Rifampin	Experimental	Drug: Apremilast, Drug: Rifampin Oral Capsules, Drug: Rifampin IV SolutionParticipants received the following 3 treatment regimens: * A single oral dose of 30 mg apremilast on Day 1 (Period 1); * A single oral dose of 30 mg apremilast followed 5 minutes later by a 30-minute intravenous infusion of 600 mg rifampin on Day 5 (Period 2); * Once daily oral doses of 600 mg rifampin for 15 days (from Day 7 to Day 21) with a single oral dose of 30 mg apremilast co-administered with the rifampin dose on Day 20 (Period 3).

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy male or female subjects of any ethnic origin between ages of 18 and 55 with a body mass index between 18 and 33

Key exclusion criteria (4 listed)

Recent history (i.e., within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, allergic or other major disorders.
Use of any prescribed or non-prescribed systemic or topical medication (including vitamins and herbal medicines, e.g. St. John's Wort) within 30 days of the first dose, unless an exception is granted by the sponsor.
Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, or plans to have elective or medical procedures during the conduct of the trial.
Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration

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
ApremilastAlso: CC-10004, Otezla®Tablets for oral administration	Drug	Apremilast and Rifampin
Rifampin Oral CapsulesAlso: RIFADIN™Capsules for oral administration	Drug	Apremilast and Rifampin
Rifampin IV SolutionAlso: RIFADIN™Intravenous (IV) solution	Drug	Apremilast and Rifampin

Primary outcome

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUCt) of Apremilast
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20
Plasma concentrations of apremilast were determined by means of a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometric (LC-MS/MS) assay.
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC∞) of Apremilast
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20
Plasma concentrations of apremilast were determined by means of a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometric (LC-MS/MS) assay.
Maximum Observed Plasma Concentration (Cmax) of Apremilast
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20
Plasma concentrations of apremilast were determined by means of a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometric (LC-MS/MS) assay.
Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20
Plasma concentrations of apremilast were determined by means of a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometric (LC-MS/MS) assay.
Estimate of the Terminal Elimination Half-life (T1/2) of Apremilast in Plasma
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20
Plasma concentrations of apremilast were determined by means of a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometric (LC-MS/MS) assay.
Apparent Total Plasma Clearance (CL/F) of Apremilast
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20
Plasma concentrations of apremilast were determined by means of a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometric (LC-MS/MS) assay.
Apparent Volume of Distribution (Vz/F) of Apremilast
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20
Plasma concentrations of apremilast were determined by means of a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometric (LC-MS/MS) assay.

Results and safety

Results posted to the registry on 9 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Apremilast and Rifampin	21	20

Primary outcome: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUCt) of Apremilast

Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Apremilast Alone n = 21	Apremilast + IV Rifampin n = 19	Apremilast + Multiple Dose Oral Rifampin n = 19
Value	3070 (31.3)	2940 (31.3)	850 (33.7)

Apremilast Alone vs Apremilast + IV Rifampin: Ratio of Geometric Least Squares Means: 96.35 (90% CI 88.56 to 104.82)
Apremilast Alone vs Apremilast + Multiple Dose Oral Rifampin: Ratio of Geometric Least Squares Means: 27.88 (90% CI 25.63 to 30.34)

Population analysed: The pharmacokinetic population included all participants who received at least one dose of apremilast and had evaluable PK profiles.

Primary outcome: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC∞) of Apremilast

Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Apremilast Alone n = 21	Apremilast + IV Rifampin n = 19	Apremilast + Multiple Dose Oral Rifampin n = 19
Value	3120 (31.5)	2980 (31.2)	869 (32.9)

Apremilast Alone vs Apremilast + IV Rifampin: Ratio of Geometric Least Squares Means: 95.71 (90% CI 87.99 to 104.12)
Apremilast Alone vs Apremilast + Multiple Dose Oral Rifampin: Ratio of Geometric Least Squares Means: 27.96 (90% CI 25.70 to 30.41)

Population analysed: The pharmacokinetic population included all participants who received at least one dose of apremilast and had evaluable PK profiles.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Apremilast

Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Apremilast Alone n = 21	Apremilast + IV Rifampin n = 19	Apremilast + Multiple Dose Oral Rifampin n = 19
Value	290 (24.5)	331 (25.1)	166 (23.2)

Apremilast Alone vs Apremilast + IV Rifampin: Ratio of Geometric Least Squares Means: 113.07 (90% CI 103.18 to 123.91)
Apremilast Alone vs Apremilast + Multiple Dose Oral Rifampin: Ratio of Geometric Least Squares Means: 56.80 (90% CI 51.84 to 62.25)

Population analysed: The pharmacokinetic population included all participants who received at least one dose of apremilast and had evaluable PK profiles.

Primary outcome: Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast

Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20. Median (Full Range). Unit: hours

Measure	Apremilast Alone n = 21	Apremilast + IV Rifampin n = 19	Apremilast + Multiple Dose Oral Rifampin n = 19
Value	2.00 (0.50 to 5.00)	1.50 (0.50 to 5.00)	1.00 (0.50 to 5.00)

Apremilast Alone vs Apremilast + IV Rifampin: Median Difference: -0.25 (90% CI -0.75 to 0.00), p = 0.2656, Wilcoxon signed rank test
Apremilast Alone vs Apremilast + Multiple Dose Oral Rifampin: Median Difference: -0.50 (90% CI -1.00 to 0.00), p = 0.1141, Wilcoxon signed rank test

Population analysed: The pharmacokinetic population included all participants who received at least one dose of apremilast and had evaluable PK profiles.

Adverse events

Time frame: Period 1 (Apremilast Alone): Day 1 to day 4; Period 2 (Apremilast + IV Rifampin): Day 5 to day 6; Period 3 (Apremilast + Multiple Dose Oral Rifampin): Day 7 up to day 32; Overall Study (All Treatment Regimens): Up to 32 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Apremilast Alone	0 of 21 (0%)	2 of 21 (9.5%)	Not reported
Apremilast + IV Rifampin	0 of 20 (0%)	4 of 20 (20%)	Not reported
Apremilast + Multiple Dose Oral Rifampin	0 of 20 (0%)	9 of 20 (45%)	Not reported
Overall Study - All Treatment Regimens	0 of 21 (0%)	12 of 21 (57.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24962564Liu Y, Zhou S, Wan Y, Wu A, Palmisano M. The impact of co-administration of ketoconazole and rifampicin on the pharmacokinetics of apremilast in healthy volunteers. Br J Clin Pharmacol. 2014 Nov;78(5):1050-7. doi: 10.1111/bcp.12448.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

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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.

MD study director

Amgen

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 Apremilast, Rifampin Oral Capsules and Rifampin IV Solution in people with Healthy Subjects, run by Amgen 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 1 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 9 Jun 2021. 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. 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?

Yes. Results are posted in the registry (first posted 9 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUCt) of Apremilast (time frame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20). The study lists 7 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 NCT01561963, 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 9 Jun 2021.