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| ID | Type | Description | Link |
|---|---|---|---|
| 70033093THR1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2019-003783-46 | EudraCT Number |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is to evaluate the potential pharmacokinetic (PK) interaction between JNJ-70033093 and digoxin in healthy participants after single dose administration and at steady state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-70033093 + Digoxin | Experimental | Participants will receive JNJ-70033093 as oral capsules (Treatment A) in Period 1, followed by digoxin tablets as loading dose and maintenance doses (Treatment B) in Period 2, and then digoxin tablets along with JNJ-70033093 (Treatment C) in Period 3. There will be a washout period of minimum 5 days (and maximum 7 days) between the last dosing day of Period 1 and the first dosing day of Period 2. There is no washout between Periods 2 and 3 (that is, the last day of Treatment B is to be followed by the first day of Treatment C). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-70033093 | Drug | Participants will receive JNJ-70033093 orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) Geometric Mean Ratio of Treatment C (JNJ-70033093 + Digoxin) Relative to Treatment A (JNJ-70033093) | Cmax is the maximum observed plasma concentration. Cmax geometric mean ratio of Treatment C (JNJ-70033093 + digoxin) relative to Treatment A (JNJ-70033093) will be reported to assess the effect of digoxin on the pharmacokinetics (PK) of JNJ-70033093. | Up to Day 21 |
| Cmax Geometric Mean Ratio of Treatment C (JNJ-70033093 + Digoxin) Relative to Treatment B (Digoxin) | Cmax is the maximum observed plasma concentration. Cmax geometric mean ratio of Treatment C (JNJ-70033093 + Digoxin) relative to Treatment B (digoxin) will be reported to assess the effect of JNJ-70033093 on the PK of digoxin. | Up to Day 21 |
| Area Under the Plasma Concentration-time Curve from Time 0 to 24 Hours Postdose (AUC [0-24 hours]) Geometric Mean Ratio of Treatment C (JNJ-70033093 + Digoxin) Relative to Treatment A (JNJ-70033093) | AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours postdose. AUC (0-24) geometric mean ratio of Treatment C (JNJ-70033093 + digoxin) relative to Treatment A (JNJ-70033093) will be reported to assess the effect of digoxin on the PK of JNJ-70033093. | Up to 24 hours postdose |
| AUC (0-24) Geometric Mean Ratio of Treatment C (JNJ-70033093 + Digoxin) Relative to Treatment B (Digoxin) | AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours postdose. AUC (0-24) geometric mean ratio of Treatment C (JNJ-70033093 + digoxin) relative to Treatment B (digoxin) will be reported to assess the effect of JNJ-70033093 on the PK of digoxin. | Up to 24 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment. Therefore, it can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| C000720754 | milvexian |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Digoxin | Drug | Participants will receive digoxin orally. |
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| Up to 63 Days |
| Number of Participants with Vital Sign Abnormalities as a Measure of Safety and Tolerability | Number of participants with vital sign (tympanic temperature, resting [supine] pulse rate, and blood pressure) abnormalities will be reported. | Up to 63 Days |
| Number of Participants with 12-lead Electrocardiogram (ECG) Abnormalities as a Measure of Safety and Tolerability | Number of participants with 12-lead ECG abnormalities will be reported. | Up to 63 Days |
| Number of Participants with Laboratory Abnormalities as a Measure of Safety and Tolerability | Number of participants with laboratory abnormalities (hematology, coagulation tests, clinical chemistry, and urinalysis) will be reported. | Up to 63 Days |
| Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT) | Percent change from baseline in aPTT will be reported. | Baseline up to Day 21 |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |