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| Name | Class |
|---|---|
| Davita Clinical Research | INDUSTRY |
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The present study is designed to assess the effects of Rifampin on the pharmacokinetics of N91115 in healthy subjects.
This study will assess the effects of multiple oral dose administration of rifampin on the steady state plasma pharmacokinetics (PK) of N91115 in healthy subjects.
Eligible subjects (n=15) will receive oral doses of N91115 twice daily (approximately every 12 hours) on Study Days 1 through the morning of Day 13. On Study Days 8 through 12, rifampin administered 600 mg once daily will be added to the N91115 regimen. Study subjects will be monitored for safety while housed in the clinical research unit (CRU) until discharge on Day 14. Pharmacokinetics will be followed from Study Day 1 through Study Day 14. A follow-up phone call will be made on Day 20 (1 day). Participation of an individual subject may last up to approximately 48 days from the time of screening until the end-of-study follow-up call.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N91115 + Rifampin | Experimental | N91115 200 mg twice daily (BID) from Study Day 1- 13, Rifampin 600 mg once daily (QD) from Study Day 8 - 12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N91115 | Drug | 200 mg BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the Potential Effects of Rifampin on N91115 Steady State Area Under the Curve (AUC) Values | To assess the effects of multiple oral dose administration of rifampin on the steady state AUC on Day 14 of N91115 in healthy subjects. | On Study Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Rifampin on the AUC vs time of Metabolites of N91115 | make a preliminary non statistical assessment on the effects of multiple oral dose administration of rifampin on steady state plasma PK of N91288 and metabolites, in healthy subjects | On Study Day 14 |
| The number of participants with adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Galloway, MD | Davita Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Anthony's Medical Plaza 1 | Lakewood | Colorado | 80228 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28209466 | Derived | Donaldson SH, Solomon GM, Zeitlin PL, Flume PA, Casey A, McCoy K, Zemanick ET, Mandagere A, Troha JM, Shoemaker SA, Chmiel JF, Taylor-Cousar JL. Pharmacokinetics and safety of cavosonstat (N91115) in healthy and cystic fibrosis adults homozygous for F508DEL-CFTR. J Cyst Fibros. 2017 May;16(3):371-379. doi: 10.1016/j.jcf.2017.01.009. Epub 2017 Feb 13. |
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| ID | Term |
|---|---|
| C000626473 | cavosonstat |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Rifampin | Drug | 600 mg QD |
|
|
To evaluate the safety and tolerability of multiple oral doses of N91115 in the presence and absence of multiple oral doses of rifampin |
| Over the 21 days of the study |
| Effects of Rifampin on N91115 and its Metabolites on Urine 12 Hour drug concentrations | To make a preliminary non statistical assessment on the effects of multiple oral dose administration of rifampin on the 12 hour steady state urine PK of N91115 and its primary metabolites in healthy subjects | Day 14 assessment |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |