Phase 1
Completed N=19
A Study Evaluating Relative Bioavailability of an Oral Suspension of Abrocitinib and Effect of an Acid Reducing Agent on the Bioavailability of Abrocitinib and Assessing the Taste of Abrocitinib Oral Formulations.
Healthy Volunteers
Source: ClinicalTrials.gov NCT04903093 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: AUCinf of Abrocitinib Following the Administration of Abrocitinib Commercial Tablet, Abrocitinib Oral Suspension Formulation 1 or Famotidine Plus Abrocitinib Commerical Tablet — 4623; 4601; 3096 nanogram*hour per milliliter (ng*hr/mL)
Summary
This study consists of 2 parts: Part A is to estimate the relative bioavailability of a single 200 mg dose of abrocitinib oral suspension (Test formulation) compared to the commercial abrocitinib tablet (200 mg) (Reference formulation). The effect of an acid-reducing agent on the pharmacokinetics of abrocitinib and its metabolites will also be evaluated by administering abrocitinib 200 mg commercial tablet with or without famotidine 40 mg, as an acid-reducing agent. Part B is to assess the taste and palatability of six different abrocitinib oral suspension formulations. Additionally, the safety and tolerability of abrocitinib tablet (in Part A) and abrocitinib oral suspension formulations (in Part B) will be assessed when given with or without famotidine 40 mg once daily.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUCinf of Abrocitinib Following the Administration of Abrocitinib Commercial Tablet, Abrocitinib Oral Suspension Formulation 1 or Famotidine Plus Abrocitinib Commerical Tablet |
4623; 4601; 3096 | — |
| PRIMARY Cmax of Abrocitinib Following the Administration of Abrocitinib Commercial Tablet, Abrocitinib Oral Suspension Formulation 1 or Famotidine Plus Abrocitinib Commerical Tablet |
1264; 1218; 189.1 | — |
| PRIMARY Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B |
42.32; 72.10; 44.95; 42.19; 71.08; 69.29 | — |
| PRIMARY Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B |
40.12; 61.59; 40.79; 42.10; 63.59; 61.59 | — |
| PRIMARY Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B |
39.25; 64.25; 32.06; 28.63; 70.76; 63.28 | — |
| PRIMARY Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B |
28.90; 41.87; 25.87; 26.89; 35.75; 41.05 | — |
| PRIMARY Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B |
19.73; 39.52; 19.84; 21.84; 39.24; 34.98 | — |
| PRIMARY Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B |
25.44; 52.54; 24.86; 25.65; 48.35; 47.37 | — |
| PRIMARY Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B |
31.16; 82.16; 30.16; 27.90; 78.48; 74.53 | — |
| SECONDARY AUCinf of Abrocitinib Metabolite (PF-06471658/M1) Following the Administration of Abrocitinib 1×200 mg Tablet With or Without Famotidine 40 mg in Part A |
1048; 903.2 | — |
| SECONDARY AUCinf of Abrocitinib Metabolite (PF-07055087/M2) Following the Administration of Abrocitinib 1×200 mg Tablet With or Without Famotidine 40 mg in Part A |
1369; 1108 | — |
| SECONDARY AUCinf of Abrocitinib Metabolite (PF-07054874/M4) Following the Administration of Abrocitinib 1×200 mg Tablet With or Without Famotidine 40 mg in Part A |
2139; 1705 | — |
| SECONDARY Cmax of Abrocitinib Metabolite (PF-06471658/M1) Following the Administration of Abrocitinib 1×200 mg Tablet With or Without Famotidine 40 mg in Part A |
216.8; 57.38 | — |
| SECONDARY Cmax of Abrocitinib Metabolite (PF-07055087/M2) Following the Administration of Abrocitinib 1×200 mg Tablet With or Without Famotidine 40 mg in Part A |
214.3; 56.42 | — |
| SECONDARY Cmax of Abrocitinib Metabolite (PF-07054874/M4) Following the Administration of Abrocitinib 1×200 mg Tablet With or Without Famotidine 40 mg in Part A |
400.5; 87.96 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Event |
6; 8; 6; 5; 2; 3 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Vital Sign Values |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Nausea AEs |
12; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female participants who are overtly healthy as determined by medical evaluation including a detailed medical history, complete physical examination, laboratory tests, and cardiovascular tests.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Capable of giving signed informed consent.
Exclusion Criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- History of human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus infection; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C virus antibody (HCVAb).
- Other acute or chronic medical or psychiatric condition including recent (within the past year).
Evidence or history of clinically significant dermatological condition (eg, atopic dermatitis or psoriasis) or visible rash present during physical examination.
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product.
- A positive urine drug test.
- Selected laboratory abnormalities.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- History of tuberculosis (TB) (active or latent).
- Any history of chronic infections, any history of recurrent infections, any history of latent infections, or any acute infection within 2 weeks of baseline.
- Pregnant female participants; breastfeeding female participants; female participants of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
- History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized dermatomal herpes zoster.
Data sourced from ClinicalTrials.gov (NCT04903093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.