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A three-part, randomized, double-blind study in healthy older adults to identify a dose of deupirfenidone for further clinical study.
A Phase 1 study to evaluate safety, tolerability, and PK in older healthy subjects of multiple twice daily (BID) or 3 times daily (TID) doses of deupirfenidone administered over 3 days compared to that of pirfenidone or placebo administered TID. The study also investigated the PK profile of deupirfenidone at steady state compared to that of pirfenidone at steady state and the effect of food on the PK profile of deupirfenidone and pirfenidone. The study was conducted in 3 parts. Part 1 was a randomized, double-blinded, two-period crossover study conducted in healthy older adults to evaluate the tolerability differentiation of BID dosing of deupirfenidone to pirfenidone. Part 2 was a randomized, double-blinded, two-period crossover study conducted in healthy older adults to evaluate the tolerability differentiation of TID dosing of deupirfenidone to pirfenidone. Part 3 was a randomized, double-blinded, parallel arm, placebo-controlled study conducted in healthy older adults to evaluate the safety and tolerability of two doses of deupirfenidone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Active | Experimental | deupirfenidone 850 mg BID |
|
| Part 1 Active Comparator | Active Comparator | pirfenidone 801 mg TID |
|
| Part 2 Active | Experimental | deupirfenidone 550 mg TID |
|
| Part 2 Active Comparator | Active Comparator | pirfenidone 801 mg TID |
|
| Part 3 Active | Experimental | deupirfenidone 550/824 mg TID |
|
| Part 3 Placebo | Placebo Comparator | placebo TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deupirfenidone | Drug | Swedish orange capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Cmax of BID deupirfenidone versus TID pirfenidone | To compare the Cmax of 850 mg BID dosing of deupirfenidone to 801 mg TID dosing of pirfenidone at steady state, in older healthy subjects, when administered in a two-period crossover design. | 14 days |
| Part 2: Cmax of TID deupirfenidone versus TID pirfenidone | To compare the Cmax of 550 mg TID deupirfenidone to 801 mg TID pirfenidone at steady state in older healthy subjects, when administered in a two-period crossover design. | 14 days |
| Part 3: Cmax of TID deupirfenidone versus placebo | To evaluate the Cmax of two doses of deupirfenidone. | 6 days |
| Part 1: AUC of BID deupirfenidone versus TID pirfenidone | To compare the AUC of 850 mg BID dosing of deupirfenidone to 801 mg TID dosing of pirfenidone at steady state, in older healthy subjects, when administered in a two-period crossover design. | 14 Days |
| Part 1: Tmax of BID deupirfenidone versus TID pirfenidone | To compare the Tmax of 850 mg BID dosing of deupirfenidone to 801 mg TID dosing of pirfenidone at steady state, in older healthy subjects, when administered in a two-period crossover design. | 14 Days |
| Part 2: AUC of TID deupirfenidone versus TID pirfenidone | To compare the AUC of 550 mg TID deupirfenidone to 801 mg TID pirfenidone at steady state in older healthy subjects, when administered in a two-period crossover design. | 14 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: The effect of food on the Cmax of BID deupirfenidone versus TID pirfenidone | To compare the Cmax of 850 mg BID dosing of deupirfenidone to 801 mg TID dosing of pirfenidone at steady state, in older healthy subjects, when administered with food on the last day of dosing prior to wash-out in a two-period crossover design. | 1 day |
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| Name | Affiliation | Role |
|---|---|---|
| Steven H Reynolds, DO | Collaborative Neuroscience Network, LLC. | Principal Investigator |
| Michael A Hassman, DO | Hassman Research | Principal Investigator |
| Bruce G Rankin, DO | Accel Research Sites | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Network, LLC. | Long Beach | California | 90806 | United States | ||
| Accel Research Sites |
This was a pharmacokinetic study with no health-based outcomes.
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| ID | Term |
|---|---|
| C093844 | pirfenidone |
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The study was conducted in 3 parts. Part 1 was a randomized, double-blinded, two-period crossover study conducted in healthy older adults to evaluate the pharmacokinetics of BID dosing of deupirfenidone to pirfenidone. Part 2 was a randomized, double-blinded, two-period crossover study conducted in healthy older adults to evaluate the pharmacokinetics of TID dosing of deupirfenidone to pirfenidone. Part 3 was a randomized, double-blinded, parallel arm, placebo-controlled study conducted in healthy older adults to evaluate the pharmacokinetics of two doses of deupirfenidone.
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Over-encapsulation of study drug
| Pirfenidone (PFD) | Drug | Swedish orange capsule |
|
| Placebo | Drug | Swedish orange capsule |
|
| Part 2: Tmax of TID deupirfenidone versus TID pirfenidone | To compare the Tmax of 550 mg TID deupirfenidone to 801 mg TID pirfenidone at steady state in older healthy subjects, when administered in a two-period crossover design. | 14 Days |
| Part 3: AUC of TID deupirfenidone versus placebo | To evaluate the AUC of two doses of deupirfenidone. | 6 Days |
| Part 3: PK profile of TID deupirfenidone versus placebo | To evaluate the Tmax of two doses of deupirfenidone. | 6 Days |
| Part 2: The effect of food on the Cmax of TID deupirfenidone versus TID pirfenidone |
To compare the Cmax of 550 mg TID deupirfenidone to 801 mg TID pirfenidone at steady state in older healthy subjects, when administered with food on the last day of dosing prior to wash-out in a two-period crossover design. |
| 1 day |
| Part 1: The effect of food on the AUC of BID deupirfenidone versus TID pirfenidone | To compare the AUC of 850 mg BID dosing of deupirfenidone to 801 mg TID dosing of pirfenidone at steady state, in older healthy subjects, when administered with food on the last day of dosing prior to wash-out in a two-period crossover design. | 6 Days |
| Part 1: The effect of food on the Tmax of BID deupirfenidone versus TID pirfenidone | To compare the Tmax of 850 mg BID dosing of deupirfenidone to 801 mg TID dosing of pirfenidone at steady state, in older healthy subjects, when administered with food on the last day of dosing prior to wash-out in a two-period crossover design. | 1 Day |
| Part 2: The effect of food on the AUC of TID deupirfenidone versus TID pirfenidone | To compare the AUC of 550 mg TID deupirfenidone to 801 mg TID pirfenidone at steady state in older healthy subjects, when administered with food on the last day of dosing prior to wash-out in a two-period crossover design. | 1 Day |
| Part 2: The effect of food on the Tmax of TID deupirfenidone versus TID pirfenidone | To compare the Tmax of 550 mg TID deupirfenidone to 801 mg TID pirfenidone at steady state in older healthy subjects, when administered with food on the last day of dosing prior to wash-out in a two-period crossover design. | 1 Day |
| Lake Mary |
| Florida |
| 32746 |
| United States |
| Hassman Research | Berlin | New Jersey | 08009 | United States |