NCT07908641Not yet recruitingPhase 1
Comparing the Extent to Which Apremilast is Made Available in the Body After Administration as an Extended-release or Immediate-release Formulation
A Phase 1, Open-label, Crossover Study to Evaluate the Relative Bioavailability of Apremilast Extended-release and Immediate Release Formulations in Healthy Adult Participants.
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
The main objective of this study is to compare the relative bioavailability, safety, and tolerability of extended-release and immediate-release apremilast formulations in healthy participants.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- First submitted
- 26 Oct 2026
- Start date
- 18 Nov 2026
- Primary completion date
- 10 Jan 2027
- Lead sponsor
- Amgen
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT07908641
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 114
- From 18 Nov 2026 to the primary completion date, 10 Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of suicidal ideation, suicide attempt, or major psychiatric illness within 6 months before informed consent.
- Malignancy within the previous 5 years, except for protocol-specified nonmelanoma skin cancers or cervical carcinoma in situ.
- Positive testing for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, except for protocol-specified hepatitis B results consistent with prior vaccination or prior infection.
- Use of prohibited prescription or over-the-counter medications, herbal medicines, vitamins, or supplements within the protocol-specified period before study entry.
- Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, before check-in.
- Previous participation in this study or another study investigating apremilast, or previous receipt of apremilast.
- Use of tobacco- or nicotine-containing products within 3 months before check-in.
Other illness
- Clinically significant medical condition or disease that may pose a safety risk or interfere with study participation or interpretation of study results.
- Significant gastrointestinal disease, gastrointestinal surgery that could affect drug absorption, malabsorption syndrome, or inability to swallow oral medication.
- Known hypersensitivity, intolerance, or allergy to apremilast.
- History of alcohol or drug abuse within the protocol-specified periods, or positive alcohol or illicit drug testing.
Lab values
- Clinically significant cardiovascular disease or ECG abnormality, including clinically significant arrhythmia or prolonged QTcF(QT Interval Corrected for Heart Rate Using Fridericia's Formula).
- Clinically significant renal or hepatic impairment, including estimated glomerular filtration rate (eGFR) \<70 mL/min/1.73 m\^²(millilitres per minute per 1.73 square meters) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.5 × the upper limit of normal.
- Recent blood, plasma, or platelet donation outside the protocol-specified limits.
Other
- Poor peripheral venous access.
- Unable or unwilling to comply with protocol-required dietary, lifestyle, or other study restrictions.
Who the study is looking for
- Healthy male or female participants, 18 to 60 years of age, inclusive.
- Body mass index (BMI) between 18.0 and 32.0 kg/m\^²(kilograms per meter square.), inclusive.
- In good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations.
- Female participants must not be pregnant or breastfeeding.
- Participants of reproductive potential must agree to follow protocol-specified contraception requirements.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.